Obesity
Conditions
Keywords
Weight loss maintenance
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.
Interventions
DIETARY_SUPPLEMENTContinuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
DIETARY_SUPPLEMENTIntermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Sponsors
University of Glasgow
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Baseline, 26 weeks | Difference between the two groups in change in body weight (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Baseline, 52 weeks, 78 weeks | Change in body weight (kg) |
| Acceptability | Baseline, 26 weeks, 52 weeks, 78 weeks | Number of clinic appointments attended as a proportion of the total number offered |
| Cost of interventions | 78 weeks | Difference between groups |
| 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) |
| Behavioural strategies | 78 weeks | Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations |
Countries
United Kingdom
Outcome results
None listed