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BEYOND Weight Loss Maintenance Study

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ClinicalTrials.gov Identifier: NCT02683798
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Continuous energy restriction Dietary Supplement: Intermittent energy restriction Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
Study Start Date : April 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day
Dietary Supplement: Continuous energy restriction
1 x formula food (202-209kcal) meal replacement per day

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




Primary Outcome Measures :
  1. Weight change [ Time Frame: Baseline, 26 weeks ]
    Difference between the two groups in change in body weight (kg)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683798


Locations
United Kingdom
NHS Lothian
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
NHS Highland
Inverness, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Principal Investigator: Michael Lean, FRCPS University of Glasgow

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02683798     History of Changes
Other Study ID Numbers: GN15HN592
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Keywords provided by NHS Greater Glasgow and Clyde:
Weight loss maintenance

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms