An interventional study of Continuous energy restriction and Intermittent energy restriction in Obesity, sponsored by NHS Greater Glasgow and Clyde. Completed at 3 sites in United Kingdom. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.
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.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's enrollment of 63 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 x formula food (202-209kcal) meal replacement per day
Dietary Supplement: Continuous energy restriction
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Dietary Supplement: Intermittent energy restriction
1 x formula food (202-209kcal) meal replacement per day
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
Weight change
Difference between the two groups in change in body weight (kg)
Time frame: Baseline, 26 weeks
Weight change
Change in body weight (kg)
Time frame: Baseline, 52 weeks, 78 weeks
Acceptability
Number of clinic appointments attended as a proportion of the total number offered
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Behavioural strategies
Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations
Time frame: 78 weeks
Eating behaviours
Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Quality of life
Change measured using EuroQoL-5D (EQ-5D)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Cost of interventions
Difference between groups
Time frame: 78 weeks
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NHS Greater Glasgow and Clyde