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BEYOND Weight Loss Maintenance Study

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Continuous energy restriction
Intermittent energy restriction
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight loss maintenance

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NHS Lothian
  • NHS Greater Glasgow and Clyde
  • NHS Highland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous energy restriction

Intermittent energy restriction

Arm Description

1 x formula food (202-209kcal) meal replacement per day

4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week

Outcomes

Primary Outcome Measures

Weight change
Difference between the two groups in change in body weight (kg)

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2016
Last Updated
April 27, 2021
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT02683798
Brief Title
BEYOND Weight Loss Maintenance Study
Official Title
Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous energy restriction
Arm Type
Active Comparator
Arm Description
1 x formula food (202-209kcal) meal replacement per day
Arm Title
Intermittent energy restriction
Arm Type
Experimental
Arm Description
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Intervention Type
Dietary Supplement
Intervention Name(s)
Continuous energy restriction
Intervention Description
1 x formula food (202-209kcal) meal replacement per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Intermittent energy restriction
Intervention Description
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Primary Outcome Measure Information:
Title
Weight change
Description
Difference between the two groups in change in body weight (kg)
Time Frame
Baseline, 26 weeks
Secondary Outcome Measure Information:
Title
Weight change
Description
Change in body weight (kg)
Time Frame
Baseline, 52 weeks, 78 weeks
Title
Acceptability
Description
Number of clinic appointments attended as a proportion of the total number offered
Time Frame
Baseline, 26 weeks, 52 weeks, 78 weeks
Title
Behavioural strategies
Description
Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations
Time Frame
78 weeks
Title
Eating behaviours
Description
Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18)
Time Frame
Baseline, 26 weeks, 52 weeks, 78 weeks
Title
Quality of life
Description
Change measured using EuroQoL-5D (EQ-5D)
Time Frame
Baseline, 26 weeks, 52 weeks, 78 weeks
Title
Cost of interventions
Description
Difference between groups
Time Frame
78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lean, FRCPS
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Lothian
City
Edinburgh
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Facility Name
NHS Highland
City
Inverness
Country
United Kingdom

12. IPD Sharing Statement

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BEYOND Weight Loss Maintenance Study

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