BEYOND Weight Loss Maintenance Study

Obesity Clinical Trial

Official title:

Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683798
• Other study ID #: GN15HN592
• Status: Completed
• Phase: N/A
• Start date: April 12, 2016
• Est. completion date: November 22, 2019

Study information

• Verified date: April 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
• Intermittent energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week

Locations

Country	Name	City	State
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	NHS Highland	Inverness

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

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