BEYOND Weight Loss Maintenance Study

Study Overview
=================
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.

Official Title
-----------------
Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Continuous energy restriction
* Dietary Supplement: Intermittent energy restriction


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss maintenance