BEYOND Weight Loss Maintenance Study

April 27, 2021 updated by: NHS Greater Glasgow and Clyde

Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom
        • NHS Lothian
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde
      • Inverness, United Kingdom
        • Nhs Highland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
Dietary supplement: Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
Experimental: Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Dietary supplement: Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: Baseline, 26 weeks
Difference between the two groups in change in body weight (kg)
Baseline, 26 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow

Investigators

  • Principal Investigator: Michael Lean, FRCPS, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2016

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN15HN592

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Continuous energy restriction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe