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Clinical Trials/NCT02683798
NCT02683798
Completed
Not Applicable

Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus

NHS Greater Glasgow and Clyde3 sites in 1 country63 target enrollmentApril 12, 2016
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
63
Locations
3
Primary Endpoint
Weight change
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2016
End Date
November 22, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Weight change

Time Frame: Baseline, 26 weeks

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

Secondary Outcomes

  • Acceptability(Baseline, 26 weeks, 52 weeks, 78 weeks)
  • Weight change(Baseline, 52 weeks, 78 weeks)
  • Behavioural strategies(78 weeks)
  • Eating behaviours(Baseline, 26 weeks, 52 weeks, 78 weeks)
  • Quality of life(Baseline, 26 weeks, 52 weeks, 78 weeks)
  • Cost of interventions(78 weeks)

Study Sites (3)

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