Clinical trial NCT02683798: BEYOND Weight Loss Maintenance Study
Official title: Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss maintenance
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2016-02-17
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Weight change
timeFrame: Baseline, 26 weeks
Secondary outcomes:
measure: Weight change
timeFrame: Baseline, 52 weeks, 78 weeks
measure: Acceptability
timeFrame: Baseline, 26 weeks, 52 weeks, 78 weeks
measure: Behavioural strategies
timeFrame: 78 weeks
measure: Eating behaviours
timeFrame: Baseline, 26 weeks, 52 weeks, 78 weeks
measure: Quality of life
timeFrame: Baseline, 26 weeks, 52 weeks, 78 weeks
measure: Cost of interventions
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Inverness
country: United Kingdom
facility: NHS Highland
Study officials:
affiliation: University of Glasgow
name: Michael Lean, FRCPS
role: PRINCIPAL_INVESTIGATOR
References: