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Completed

NCT Number: NCT02683798

BEYOND Weight Loss Maintenance Study

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Lothian, Edinburgh, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous energy restriction

Dietary Supplement

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

Intermittent energy restriction

Dietary Supplement

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

Primary outcomes

  1. Weight change

    Time frame: Baseline, 26 weeks

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

Secondary outcomes

  1. Weight change

    Time frame: Baseline, 52 weeks, 78 weeks

    Change in body weight (kg)

  2. Acceptability

    Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks

    Number of clinic appointments attended as a proportion of the total number offered

  3. Behavioural strategies

    Time frame: 78 weeks

    Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations

  4. Eating behaviours

    Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks

    Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18)

  5. Quality of life

    Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks

    Change measured using EuroQoL-5D (EQ-5D)

  6. Cost of interventions

    Time frame: 78 weeks

    Difference between groups

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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