Continuous energy restriction
Dietary Supplement1 x formula food (202-209kcal) meal replacement per day
NCT Number: NCT02683798
A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
NHS Lothian, Edinburgh, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline, 26 weeks
Difference between the two groups in change in body weight (kg)
Time frame: Baseline, 52 weeks, 78 weeks
Change in body weight (kg)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Number of clinic appointments attended as a proportion of the total number offered
Time frame: 78 weeks
Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Change measured using EuroQoL-5D (EQ-5D)
Time frame: 78 weeks
Difference between groups
NHS Greater Glasgow and Clyde
Other
Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
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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