Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Stewart 2015

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs

Literature search up to November 2014 (Medline), December 2014 (Embase, CINAHL, PsycINFO, Cochrane),

Preoperative interventions

A: Solomon 2009

Postoperative interventions

B: Coen 2013

C: Nijamkin 2012

D: Swenson 2007

Study design: RCT

Setting and Country:

Review: Health Services Research Unit, University of Aberdeen, UK

A: USA

B: USA

C: USA

D: USA

Source of funding and conflicts of interest:

The authors declare that they have no competing

interests.

The Health Services Research Unit, University of Aberdeen,

is funded by the Chief Scientist Office of the Scottish Government Health

Directorates. The views expressed are those of the authors.

Inclusion criteria SR:

Eligible trials had to be RCTs or quasi-RCTs, open only to

adults (age ≥18 years or any given definition of adult) with BMI ≥35 kg/m2 with significant co-morbidities or BMI

≥40 kg/m2, undergoing any kind of BS. Any behavioural interventions

were eligible, with the explicit aim of changing behaviour related to diet and/or physical activity, starting

within 12 months of surgery, either pre- or post-operatively.

A minimum of 6 months’ follow-up was specified.

Eligible comparators were usual or standard care, waiting

list control or no intervention. Eligible studies had to report the

primary outcome of weight change, e.g. weight, excess weight loss or BMI.

Exclusion criteria SR:

pharmacological interventions, complementary

therapies and conference abstracts without full-text publications.

11 studies were included in the review of which 4 studies fulfilled the inclusion criteria of the research question.

Important patient characteristics at baseline:

Number (I/C)

A: 50/ 50

B: 66/ 62

C: 72/ 72

D: 19/ 13

Age, mean (SD)

A: 42.4 (10.5)/ 44.9 (7.8)

B: 41.3 (9.7)/ 41.9 (10.3)

C: 44.2 (12.6)/ 44.8 (14.4)

D: 41.7 (9.1)/ 39.7 (7.6)

Sex, % female:

A: 88/ 80

B: 89/ 87

C: 86/ 81

D: 95/ 84

Weight (kg), mean (SD)

A: 130.9 (18.2)/ 138.7 (21.7) 49.2

B: 107.3 (19.9)/ 105.7 (25.1)

C: 94.6 (21.2)/ 100.3 (24.9)

D: 197.5 (85.0)/ 166.5 (71.0)

BMI (kg/ m2), mean (SD)

A: 48.7 (range 42–55)/ 49.2 (range 43–46)

B: 38.8 (6.1)/ 38.3 (6.9)

C: 35.4 (6.83)/ 36.5 (7.0)

D: 50.7 (8.7)/ 46.3 (9.4)

Procedure

A: Gastric bypass

B: Gastric bypass

C: Gastric bypass

D: Gastric bypass

Groups comparable at baseline? Yes

Describe intervention:

A: Asked to achieve ≤10 %excess weight loss

(EWL) pre-operatively

B: Health education sessions+semisupervised

exercise programme

C: Dietary counselling. Advised to consume

1000–1400 kcal and 60–70 g protein per day

D: High protein diet: South Beach Diet

Describe control:

A: No intervention

B: Health education sessions alone

C: Brief printed guidelines for healthy eating

and physical activity

D: Standard post-operative low fat diet

End-point of follow-up (months):

A: 12

B: 6

C: 12

D: 12

For how many participants were no complete outcome data available?

Where participant withdrawal was reported, some

studies experienced high rates of attrition in all arms. One

study (B) offered financial incentives to all participants for completing baseline and final assessments and achieved a high completion rate, although withdrawal was slightly higher in the intervention group (6/66) than in the control group

(3/62). Studies with smaller sample sizes were more likely to have high attrition.

Outcome measure-1 Weight loss

Defined as Percent Excess Weight Change (% EWC) at 12 months

Effect measure: MD (95% CI)

A: mean (SD not reported): -78.4/ -71.3

C: -15.80 (-21.08 to -10.52)

D: 0.70 (-11.05 to 15.45)

Defined as Weight Change (kg) at 12 months

Effect measure: MD (95% CI)

A: 0.10 (-10.96 to 11.16)

C: -7.00 (-10.47 to -3.53)

Outcome measure-2 Resolution of comorbidities

Defined as differences in mean co-morbidities

A: 0.3/ 0.7

Outcome measure-3 Quality of life

Not reported

Outcome measure-4 Lifestyle change

Not reported

Author’s conclusion

Delivering behavioural interventions in addition to BS appears to result in improved post-operative weight loss outcomes for people with severe obesity. The evidence base is stronger for post-operative interventions than for delivering interventions

pre-operatively. However, these conclusions should be

interpreted with caution; the evidence presented here is limited by the relatively small number of trials identified and by their low methodological quality and short follow-up duration. Well-designed RCTs with at least two years’ post-operative follow-up are required to evaluate the effectiveness of behaviour

change and dietary support with physical activity.

Ren, 2018

PS., study characteristics and results are extracted from the SR (unless stated otherwise)

SR and meta-analysis of RCTs

Literature search up to May 2018

A: Castello 2011

B: Coleman 2016

C: Hassannejad 2017

D: Mundbjerg 2018

E: Herring 2017

F: Coen 2015

Study design: RCT

Setting and Country:

SR: China

A: USA

B: USA

C: Iran

D: Denmark

E: England

F: USA

Source of funding and conflicts of interest:

The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests: None declared.

Inclusion criteria SR:

(1) All of the published RCTs on physical exercise in patients after bariatric surgery were considered for inclusion;

(2) Subjects were adults with obesity (age ≥18 years)

who had undergone bariatric surgery (all types); (3) For

the intervention group(s), modes of exercise regimens

were defined as aerobic exercise, resistance training or a combination of both. The control group received only

standard care (eg, advice to increase physical activity

and healthy eating) or no exercise training; (4) At a

minimum, the studies must have assessed weight loss or physical function as an outcome and must have reported

mean values or the differences between the mean values.

Exclusion criteria SR:

(1) intervention

studies comparing only two kinds of exercise prescriptions

without control groups and (2) duplicate publications

of the included trials.

8 studies were included in the review of which 6 studies fulfilled the inclusion criteria of the research question.

Important patient characteristics at baseline:

Number of patients

A: 32

B: 51

C: 60

D: 60

E: 24

F: 128

Mean age (SD)

A: 38 (13.3)/ 36 (12.6)

B: 49.8 (11.4)

C: 35.4 (8.1)/ 36.7 (6.2)

D: 42.3 (9.4)/ 42.4 (9.0)

E: 48.4 (8.9)

F: 41.3 (9.7)/ 47.9 (10.3)

Mean time since

Surgery

A: 1 month

B: 14 months

C: Immediately after

D: 6 months

E: 19.3 months

F: 1–3 months

Groups comparable at baseline? Unclear

Describe intervention:

A: Aerobic exercise 60 min/d * 3 d/w * 12 w

B: Strength, flexibility

and aerobic

activities

60 min/d * 2 d/w * 6M

exercise classes +

≥3 d/w self-directed

exercise * 6 M

C: Aerobic strength

training

1–4 w:

walking ≥150 min/w

5–12 w:

walking ≥150 min/w

+strength exercise

20–30 min/d * 3×/w

D: Aerobic and

resistance training

40 min supervised

physical training

sessions * 2/w * 26 w

E: Moderate-intensity

aerobic and

resistance training

60 min gym sessions

* 3×/w * 12 w

F: Aerobic exercise

training

1–3 M: 10–15 min/d

* 3–5 w

3–6 M: 30 min/d,

120 min/w

Describe control:

A: Control group

B: Regular post-operative care

C: Control group

D: Standard information about the importance

of physical activity

E: usual follow-up care

F: Health education control

End-point of follow-up:

A: 4 months

B: 6 months

C: 12 weeks

D: 24 months

E: NR

F: 6 months

For how many participants were no complete outcome data available?

All included trials described the reasons for patients lost-to-follow-up in detail (not further described in SR)

Outcome measure-1

Mean change in body weight (kilogram)

Effect measure: WMD (95% CI)

A: 0.00 (-3.32 to 3.32)

B: -4.00 (-6.78 to -1.22)

C: -4.90 (-8.06 to -1.74)

D: -1.60 (-3.37 to 0.17)

E: -3.40 (-5.59 to -1.21)

F: -0.80 (-2.67 to 1.07)

Outcome measure-2

Remission of comorbidities

Systolic blood pressure

A: 146.6±4.0/ 150.0±7.1

D: 123.9 (22.0)/ 125.9 (SD 16.0)

E: -6.96 (SD 9.2)/ 0.4 (SD 6.7)

F: 115.5 (11.9)/ 117.3 (12.8)

HbA1c (mmol/L)

D: 34.1 (4.1)/ 36.6 (7.5)

Glucose (mmol/L)

D: 5.3 (0.4)/ 5.5 (0.8)

Fasting glucose, mg/dl

F: 84.1 (7.9)/ 85.6 (11.1)

Total cholesterol (mmol/L)

D: 4.4 (0.6)/ 4.0 (0.8)

F: 152.0 (31.5)/ 144.6 (28.1) (baseline differences)

Outcome measure-4 Lifestyle change

Calorific intake (kcal)

E: − 209.2±478.5/ 152.4±560.7

Moderate to vigorous physical activity

E: 7.5±19.8/ − 3.4±16.2

Step count (per day)

E: 242.7±2358.1/ 30.4±2300.2 (baseline differences)

Author’s conclusion

Physical exercise after bariatric surgery

provides 1.94 kg additional weight loss and 29.67 m longer 6MWD compared with surgery alone. Moreover, engaging in exercise 1 year or more after surgery, and a combined aerobic and resistance training programme may result in greater weight loss.

Personal remarks on study quality, conclusions, and other issues (potentially) relevant to the research question

Level of evidence: GRADE (per comparison and outcome measure) including reasons for down/upgrading

Sensitivity analyses (excluding small studies; excluding studies with short follow-up; excluding low quality studies; relevant subgroup-analyses); mention only analyses which are of potential importance to the research question

Heterogeneity: clinical and statistical heterogeneity; explained versus unexplained (subgroup analysis)

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Kalarchian, 2013

Type of study: RCT

Setting and country: Bariatric Center of Excellence at a large, urban medical center, USA

Funding and conflicts of interest: Research supported by R01DK077102 from the National Institute of Diabetes and Digestive and Kidney Diseases. The authors have no conflicts of interest.

Inclusion criteria: All patients who were at least 18 years of age and seeking bariatric surgery at a Bariatric Center of Excellence.

Exclusion criteria: 1) Mental retardation or psychosis; 2) Previously diagnosed genetic obesity syndrome; 3) Participation in a weight management program in the 6 months prior to study enrollment; 4) Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment; 5) Pregnant or lactating in the previous 6 months; 6) Taking a medication known to affect body weight in the previous 6 months (e.g., second generation antipsychotics); 8) Any previous weight loss surgery; 9) Medical condition requiring a specialized preoperative regimen (e.g., nonambulatory, on oxygen therapy for chronic obstructive pulmonary disease); and 10) Participation in a conflicting research protocol.

N total at baseline:

Intervention: 121

Control: 119

Important prognostic factors²:

Age

45.2 SD 11 years

Sex:

86.7% female

BMI, mean

47.9 SD 6.7 kg/m2

Groups comparable at baseline? Patients randomized to LIFESTYLE and USUAL CARE did not differ significantly in baseline BMI or demographic characteristics. However, only characteristics of all participants are provided.

Describe intervention (treatment/procedure/test):

LIFESTYLE patients participated in an intervention adapted from the behavioral weight management program. Adaptations included providing information about how surgery facilitates weight loss, emphasizing the role of self-management, and addressing factors that have been related to postoperative weight control such as eating behaviors and mood.

The objective of the behavioral intervention was to decrease calorie intake through diet and increase energy expenditure through physical activity. Participants were given a goal of 1200–1400 calories per day and instructed to stay within the range while maintaining a balanced diet consistent with nutritional guidelines for bariatric surgery. Participants were prescribed an exercise program based on their choice of activity (e.g., walking or swimming). Strategies for increasing lifestyle activity (e.g., taking the stairs or getting off the bus a stop early) were emphasized. Participants were assisted in self-monitoring and setting small, incremental goals for behavior change. The skills required to make the recommended changes in diet and physical activity were modeled, practiced, and reinforced throughout the intervention.

The lifestyle intervention lasted approximately 6 months (8 weekly face-to-face sessions, followed by 16 weeks of alternating face-to-face sessions and telephone coaching). A combination of face-to-face sessions and telephone coaching was utilized to minimize participant burden and maximize the intensity of counseling. Face-to-face sessions lasted 1 hour, consisting of a weigh-in, review of self-monitoring records, a didactic presentation, and homework. Telephone coaching was shorter in duration (15 – 20 minutes) and included a review of progress, problem solving and goal setting. Interventionists received training in behavioral and surgical management of obesity and regular supervision.

Describe control (treatment/procedure/test):

USUAL CARE patients did not have any additional contact with the study staff until the 6 month assessment. As required by health insurance carriers, patients completed a non-standardized, physician-supervised diet and activity program in the context of routine presurgical care. Most patients were seen once a month for 6 months, either in group sessions provided under

Length of follow-up:

6 months

Loss-to-follow-up:

Intervention:

18 (15%)

Reasons: inactivated after randomization: 7 provided specific reasons, 11 unknown

Control:

36 (29%)

Reasons: inactivated after randomization: 7 provided specific reasons, 11 unknown

1 died

Outcome measures and effect size (include 95%CI and p-value if available):

Weight loss

Defined as weight loss between baseline and 6 months follow-up (kg)

I: 8.3 SD 7.8 kg

C: 3.3 SD 5.5 kg

F(1,182) = 23.6, p < 0.0001

Author’s conclusion

A behavioral lifestyle intervention for severely overweight individuals leads to clinically significant weight loss prior to bariatric surgery. Post-surgery follow-up will allow us to examine the impact of the preoperative intervention on postoperative outcomes.

Bond, 2015

Type of study: RCT

Setting and country: USA

Funding and conflicts of interest: This research was supported by a grant from the National Institutes of Health/National Institute of Diabetes & Digestive & Kidney Diseases (DK083438, PI: Bond).

The authors have no competing interests.

Inclusion criteria:

Participants were 80 ambulatory individuals aged 18–70 years old with severe obesity (body mass index (BMI) ≥35 kg/m2) who were seeking bariatric surgery. Participants had to report being able to walk ≥2 blocks unassisted, but report insufficient PA (i.e. <150 MVPA minutes/week accumulated in bouts ≥10 minutes as per national guidelines).

Exclusion criteria:

Individuals were deemed ineligible if they were scheduled for a bariatric operation within 10 weeks of initial screening or during the intervention period, currently participating in another PA or weight loss program, intended to move to another geographic location during the course of the study, or had medical, psychiatric, or language barriers that would interfere with ability to participate in and follow the study protocol.

N total at baseline:

Intervention: 42

Control: 38

Important prognostic factors²:

Age, mean (SD):

I: 44.2 (9.2)

C: 48.1 (8.1)

Sex:

I: 15% M

C: 11.4% M

BMI, mean (SD)

I: 45.6 (7.0)

C :44.4 (5.8)

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Physical activity intervention (PAI) consisted of 6 consecutive weekly individual face-to-face counseling sessions with the primary author at a single site (in addition to receiving standard pre-surgical care). Sessions lasted 30–45 minutes, were conducted using a counselor manual and lesson handouts for participants, and included the following activities: reviewing participants’ PA self-monitoring records; problem-solving barriers to achieving intervention goals; teaching behavioral and cognitive strategies to achieve intervention goals; setting weekly bout-related walking exercise and step goals; developing an action plan for when, where, and how the target amount of bout-related walking exercise would be achieved; and explaining homework assignments focusing on application of PA behavior change strategies. PAI strategies were drawn from the Diabetes and Prevention Program and Look AHEAD trials, and health behavior change theories that have been successfully applied to increase PA in obese individuals.

Describe control (treatment/procedure/test):

Standard care participants attended scheduled preoperative clinic visits and received standard preoperative care. Surgeons and support staff advised participants to adopt an active lifestyle but did not provide a formal prescription or behavioral tools (e.g., pedometer) and strategies to increase PA.

Length of follow-up: ~6 weeks (post-intervention)

Loss-to-follow-up:

Intervention:

2 (5%)

Had surgery prior to completion

Control:

3 (8%)

2 had surgery prior to completion, 1 had family emergency

Outcome measures and effect size (include 95%CI and p-value if available):

Weight loss change

I: −0.1 ±2.4 kg

C: 0.1 ± 2.3 kg

Quality of life

PCS, mean (SD)

I: 44.3 (9.1)

C: 39.6 (9.2)

MCS, mean (SD)

I: 49.2 (10.1)

C: 47.7 (13.3)

Lifestyle changes

Defined as change in daily bout-related moderate-to-vigorous physical activity measured with a SenseWear Armband

I: 16.6 ± 20.7 min/d

C: −0.3 ± 12.7 min/d

Author’s conclusion

Increasing physical activity preoperatively improves physical and mental HRQoL in bariatric surgery candidates. Future studies should examine whether this effect improves surgical safety, weight loss outcomes, and postoperative HRQoL.

Camolas, 2016

Type of study: RCT

Setting and country: Obesity Treatment Unit of a Portuguese hospital

Funding and conflicts of interest:

Funding not reported.

The authors declare that they have no competing interests.

Inclusion criteria: patients with obesity Class III or Class II (in this case, with at least one comor-bidity) were considered eligible for obesity surgery and included.

Exclusion criteria: Pregnant patients and/or patients with diagnosed mental impairment were excluded.

N total at baseline:

Intervention: 68

Control: 79

Important prognostic factors²:

age ± SD:

I: 46.31 ± 13.65

C: 43.53 ± 13.92

Sex:

I: 82.2% female

C: 79.6% female

BMI, mean ± SD

I: 42.81 ± 4.96

C: 43.45 ± 7.04

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

Nutritionists received training/ supervision regarding INDIVIDUO’s procedures. INDIVIDUO is based our on principles from the transtheoretical model of health behavior change, the self-determination theory and motivational interviewing. Four main techniques define the interaction with patients: asking open questions; expressing empathy; signaling discrepancy, and; contributing to enhanced self-efficacy. As an example, nutritionists may use an adapted version of the usual twenty-four hour food recall (or usual24-h food recall), based on: (a) open question, to identify established habits/routines; (b) active listening, enabling discussion about perceptions and beliefs on eating behavior, and; (c) empathy for perceived constraints, regarding food access and choices (clinical, economic, cultural, etc.). Tailored dietary advice would: (a) promote awareness of discrepancies between eating behaviours and related values, (b) value the patients’ past/present strategies that are convergent with health-gain needs, (c) contribute to the patients’ perception of self-efficacy and (d) enhance change-talk.

INDIVIDUO uses three key principles for nutritional strategy selection and goal setting: (a) basic nutritional needs satisfaction; (b) therapeutic (weight and metabolic control) needs, and; (c) adequacy to individuals’ daily routines and constraints (personal agenda and values, financial limitations, et cetera.).

Describe control (treatment/procedure/test):

the control-group intervention was restricted to a health literacy-promoting intervention, within the con-text of a formal appointment with a nutritionist. This health-education intervention was based on the delivery and discussion of two documents: a leaflet with a list of weight-reduction strategies(similar to the ones proposed for the intervention group) and another leaflet describing a standard hypocaloric dietary plan, providing about 1800 kcal/day divided across six meals (similar to baseline recommendations used for intervention group, without personalisation of the meal plan). The main characteristics of the interaction with controls took into consideration the national guidelines, which establish that multidisciplinary evaluation prior to obesity surgery must include nutritional guidance about healthy dietary habits and their modifications after surgery. Accordingly, participants of the control group were also informed about the typical diet after obesity surgery.

Length of follow-up:

6 months

Incomplete outcome data:

Before baseline measurement

Intervention:

23 (32%)

16 no-shows

6 declined

1 BMI< 35

Control:

30 (31%)

22 no-shows

3 declined

5 BMI<35

After baseline measurement

Intervention:

16 (24%)

1 declined further follow-up

15 missed 2 appointments

Control:

18 (23%)

3 declined further follow-up

15 missed 2 appointments

Outcome measures and effect size (include 95%CI and p-value if available):

Percentage of excessive weight loss

I: 9.68%

C: 0.51%

Resolution of comorbidities

Fasting glycemia* (mg/dl), mean (SD)

I: −1.91 (6.72)

C: 1.24 (8.65)

Hemoglobin A1c (%)*

I: −0.13 (0.33)

C: −0.05 (0.18)

Systolic blood pressure (mmHg)*

I: −2.07 (10.67)

C: −1.89 (8.92)

Diastolic blood pressure (mmHg)*

I: −2.68 (9.18)

C: −3.13 (7.58)

*corrected for medication

intensification (patients extracted from analysis)

Quality of life

Defined as improvement on ORWELL-R total score

I: −11.04

C: −6.58

Favoring intervention

Author’s conclusion

Results on weight and metabolic control support INDIVIDUO as a valuable clinical tool for obesity surgery candidates counseling. Additionally, intervention associated with perceived competence for weight-control behaviours and autonomous regulation.

Macron, 2017

Type of study: RCT

Setting and country: Bariatric Surgery Department, Hospital de Clinicas de Porto Alegre, Brazil

Funding and conflicts of interest:

The study was supported by the Hospital de

Clínicas de Porto Alegre Research and Events Incentive Fund (FIPE), Higher Education Coordination of Improvement (CAPES).

The authors declare that they have no conflict of interest.

Inclusion criteria:

morbidly obese

patients (grade III or severe obesity) who participated in the bariatric surgery program at Hospital de Clínicas de Porto Alegre, Brazil, from August 2011 to September 2014. Eligible participants were all adults aged 18 years or over with

BMI >40 kg/m2, on medical treatment for more than 2 years (according Brazilian Health System Guidelines), who were referred for bariatric surgery and agreed to participate in the

study.

Exclusion criteria: Contraindication to physical activity

or being currently engaged in any type of supervised

exercise, patients with cardiovascular disease with reduced

functional capacity (classes III and IV of the New York

Heart Association), orthopedic problems, severe retinopathy,

severe neuropathy, drug addiction, severe mental illness,

or major metabolic decompensation characterized by fasting

blood glucose above 250 mg/dL, or blood pressure imbalance

characterized by systolic pressure above 200 mmHg or diastolic

pressure above 100 mmHg. In cases of uncontrolled hypertension and diabetes, the patient was initially controlled and their eligibility in the study was reevaluated after

stabilization.

N total at baseline:

Intervention1: 22

Intervention2: 22

Control: 22

Important prognostic factors²:

age ± SD:

I1: 43.4 ± 2.3

I2: 50.1 ± 2.8

C: 42.5 ± 2.7

Sex:

I1: 81.8% female

I2: 100%

C: 88.9% female

BMI, mean ± SD

I1: 50.8 ± 9.6

I2: 45 ± 4.1

C: 47.1 ± 7.6

Weight

I1: 131 SE 6.5

I2: 112.6 SE 4.6

C: 121 SE 5.8

Glucose

I1: 110.2 SE 9.2

I2: 107.2 SE 11.1

C: 105 SE 7.1

Total cholesterol

I1: 186.9 SE 7.4

I2: 190.8 SE 5.7

C: 188 SE 10.6

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

I1: Exercise group

Routine treatment at the

bariatric surgery outpatient clinic + 4-month low-intensity exercise program twice-weekly supervised exercise program of 25 minutes

I2: Exercise + lifestyle modification group

Routine treatment at the

bariatric surgery outpatient clinic + 4-month low-intensity exercise program twice-weekly supervised exercise program of 25 minutes + support group program for lifestyle modification, with a cognitive-behavioral approach, once a week.

Describe control (treatment/procedure/test):

Control group

Routine treatment at the

bariatric surgery outpatient clinic

Length of follow-up: 19 weeks

Loss-to-follow-up:

After randomization,

5 individuals in the I2 withdrew from treatment after 2 or 3 sessions (1 because surgery was anticipated and 4 were unable to attend intervention) and were therefore excluded from the analysis.

In the CONTROL, 4

individuals did not participate in the final assessment (1

changed address and 3 were contacted repeatedly but did not attend the assessment).

All patients in I1 completed the program and were analysed.

Adherence to program

I1: 80.9 (SD 10.8)

I2: 75.1 (SD 13.6)

Outcome measures and effect size (include 95%CI and p-value if available):

Weight

I1: 123.5 SE 6.5

I2: 108.5 SE 4.7

C: 124 SE 6

Resolution of comorbidities

Glucose

I1: 99 SE 6.3

I2: 102.6 SE 9.8

C: 116.1 SE 8.5

Total cholesterol

I1: 178.6 SE 6.7

I2: 185.1 SE 7.6

C: 194.3 SE 12.3

Author’s conclusion

A 4-month, twice-weekly supervised program of

low-intensity physical activity that encourages individuals to

adopt a more active lifestyle can positively interfere with

weight loss and improvement in functional capacity and cardiometabolic parameters of morbidly obese individuals with and without the aid of support group sessions.

Kalarchian, 2016

Type of study: Pilot RCT

Setting and country: USA

Funding and conflicts of interest: Research supported by a grant from Nutrisystem administered by The Obesity Society.

1 author reports serving as a

Scientific Advisory Board member for Weight Watchers International, Inc. 1 author reports grants from Covidien/ Ethicon and serving as a project consultant to Apollo

Endosurgery. 2 authors report no potential conflicts of interest.

Inclusion criteria: Gastric bypass between 10 and 14 months previously; 18 to 65 years of age; and no other weight-related research study or weight loss

program in previous 6 months.

Exclusion criteria: food allergies (e.g., peanut, soy) or major medical condition that would restrict diet; pregnant or planning to become pregnant in next 6

months; currently taking weight altering medications (such as oral steroids or antipsychotic agents); and severe mental health issues (such as psychosis or other uncontrolled symptoms requiring immediate treatment).

N total at baseline:

Intervention: 20

Control: 20

Important prognostic factors²:

age ± SD:

I: 47.8 (12.1)

C: 46.0 (10.2)

Sex:

I: 85% female

C: 85% female

BMI ± SD

I: 31.1 (5.7)

C: 31.4 (5.2)

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

See control +

4-month structured dietary intervention including home deliveries of portion-controlled foods and a personalized menu plan that incorporated fresh grocery items. The prepackaged, portion-controlled foods were selected individually by

each participant. Participants also received menus that incorporated

three small meals and one to two snacks per day, accommodating individual patient preferences and dietary restrictions. The standard Nutrisystem program instructed customers to add two to four high quality proteins, one to two low-glycemic, nutrient-rich carbohydrates, and four servings of vegetables. Participants were provided a list of foods and serving sizes for each of these categories and were

informed that they did not need to eat all of the food provided and to focus on maintaining adherence to standard postsurgery dietary guidelines.

Describe control (treatment/procedure/test):

All participants received brief instruction in behavioral weight control

adapted for bariatric surgery patients, which included one 60-min group session and handouts emphasizing self-monitoring and

behavioral strategies including goal setting, stimulus control, and

self-reinforcement. Surgery-specific strategies included eating slowly, chewing well, eating protein first, limiting liquid calories and avoiding grazing. All patients were provided with standard

postoperative dietary recommendations and calorie goals for 1 to 2

pounds weekly weight loss based on initial body weight (approximately

1,250–1,500 kcal).

Length of follow-up: 6 months postintervention

Loss-to-follow-up:

Intervention:

3 missed assessment

Control:

5 missed assessment

Outcome measures and effect size (include 95%CI and p-value if available):

Weight loss at 6 months

I: -4.07%

C: 0.14%

P=0.05

Quality of life

Defined as Participant Impact of Weight on Quality of Life (IWQOL-Lite) (100 represents the best quality of life)

I: 91.6 (SD 2.1)

C: 89.1 (SD 2.2)

Calorie intake

Change from baseline at 4 months:

I: -108

C: 116

At 6 months, change in average daily calorie consumption from baseline did not differ significantly between intervention and control participants.

Author’s conclusion

A structured dietary intervention increased weight loss and reduced calorie intake when initiated 1 year following Roux-en-Y gastric bypass. This approach holds promise for optimizing postsurgery

lifestyle change.

Study

First author, year

Appropriate and clearly focused question?¹

Yes/no/unclear

Comprehensive and systematic literature search?²

Yes/no/unclear

Description of included and excluded studies?³

Yes/no/unclear

Description of relevant characteristics of included studies?⁴

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?⁵

Yes/no/unclear/notapplicable

Assessment of scientific quality of included studies?⁶

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?⁷

Yes/no/unclear

Potential risk of publication bias taken into account?⁸

Yes/no/unclear

Potential conflicts of interest reported?⁹

Yes/no/unclear

Stewart 2016

Yes

Yes

Included: yes, excluded: no

Yes

Not applicable

Yes

Yes

Unclear

Review: yes, included studies: unclear

Ren 2018

Yes

Yes

Included: yes, excluded: no

No, BMI/ weight not reported

Not applicable

Yes

Yes

Yes

Review: yes, included studies: unclear

Study reference

(first author, publication year)

Describe method of randomisation¹

Bias due to inadequate concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Kalarchian, 2013

Participants were block randomized to behavioral lifestyle intervention or usual preoperative care, with stratification by BMI.

Unclear

Likely

Likely

Unclear

Likely

Likely

Likely

Bond, 2015

Participants were randomly assigned 1:1 to PAI or SC using a computer-generated random sequence. Condition assignment was revealed to the participant after completion of the baseline assessment.

Unclear

Likely

Likely

Unclear

Unlikely

Unlikely

Likely

Camolas, 2017

Eligible patients were stratified by sex and age groups (Younger: <40 years old; Middle-aged: 40—59years; Older: >59 years old), from which (subsample group) patients were randomly assigned to either the intervention or control group.

Unclear

Likely

Likely

Unclear

Unlikely

Likely

Likely

Macron 2017

The randomization sequence was created before the start of the trial using blocks of 12 participants and concealed in opaque, sealed envelopes by an investigator with no involvement in patient selection and who was blinded to the results of baseline ssessments (single blind).

Unlikely

Likely

Likely

Unclear

Unlikely

Likely

Likely

Kalarchian, 2016

After completing a baseline assessment, participants were stratified

by body mass index (BMI) (< or ≥30 kg/m2) and randomly

assigned to either a 4-month structured dietary intervention or to a comparison group.

Unclear

Likely

Likely

Unclear

Unlikely

Unlikely

Unlikely