BEYOND Weight Loss Maintenance Study

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Continuous energy restriction; Dietary Supplement: Intermittent energy restriction

• Registration Number: NCT02683798
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.

Detailed Description

Introduction: Long-term maintenance of non-surgical weight loss remains the most significant problem in obesity treatment. This study will compare the effectiveness of two different weight loss maintenance strategies used as part of the Counterweight Plus weight management programme. This study will also evaluate the behavioural impact of the Counterweight Plus interventions and include process evaluations and cost analysis.

Methods: 80 patients and 10 practitioners will be recruited into the study. Main inclusion criteria for patients are:

Completed Counterweight Plus, which includes 12-20 weeks total diet replacement (TDR), 8 weeks food reintroduction (FR) and achieved \>10kg weight loss. All participants will be followed up for 18 months in total.

Results: The primary outcome of this study is the difference in weight change between the two groups at 6 months. Frequency of use of behavioural strategy will be quantified for both practitioners and patients during voice recorded consultations. The relationship between weight change and the use of behavioural strategy will be assessed.

Hypothesis: This study will establish if the novel intermittent use of formula diet strategy is more effective at preventing weight regain in comparison to usual care. It will also provide evidence of the frequency of use of behavioural strategies within routine Counterweight Plus delivery, as well as establishing the cost of the intervention.

Study Timeline

• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Study Start: 2016-04-12
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Completed Counterweight Plus Total Diet Replacement and Food Reintroduction stages and achieved >10kg weight loss

Exclusion Criteria

• People currently participating in another clinical research trial (not including BEYOND Weight Loss study)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous energy restriction	Continuous energy restriction	1 x formula food (202-209kcal) meal replacement per day
Intermittent energy restriction	Intermittent energy restriction	4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week

Primary Outcome Measures

Name	Time	Method
Weight change	Baseline, 26 weeks	Difference between the two groups in change in body weight (kg)

Secondary Outcome Measures

Name	Time	Method
Acceptability	Baseline, 26 weeks, 52 weeks, 78 weeks	Number of clinic appointments attended as a proportion of the total number offered
Weight change	Baseline, 52 weeks, 78 weeks	Change in body weight (kg)
Behavioural strategies	78 weeks	Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations
Eating behaviours	Baseline, 26 weeks, 52 weeks, 78 weeks	Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18)
Quality of life	Baseline, 26 weeks, 52 weeks, 78 weeks	Change measured using EuroQoL-5D (EQ-5D)
Cost of interventions	78 weeks	Difference between groups

Trial Locations

Locations (3)

NHS Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

NHS Highland; 🇬🇧 Inverness, United Kingdom