NCT02683798

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable obesity

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 12, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3.6 years

First QC Date

February 9, 2016

Last Update Submit

April 27, 2021

Conditions

Keywords

Weight loss maintenance

Outcome Measures

Primary Outcomes (1)

  • Weight change

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

    Baseline, 26 weeks

Secondary Outcomes (6)

  • Weight change

    Baseline, 52 weeks, 78 weeks

  • Acceptability

    Baseline, 26 weeks, 52 weeks, 78 weeks

  • Behavioural strategies

    78 weeks

  • Eating behaviours

    Baseline, 26 weeks, 52 weeks, 78 weeks

  • Quality of life

    Baseline, 26 weeks, 52 weeks, 78 weeks

  • +1 more secondary outcomes

Study Arms (2)

Continuous energy restriction

ACTIVE COMPARATOR

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

Dietary Supplement: Continuous energy restriction

Intermittent energy restriction

EXPERIMENTAL

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

Dietary Supplement: Intermittent energy restriction

Interventions

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

Continuous energy restriction

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

Intermittent energy restriction

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed Counterweight Plus Total Diet Replacement and Food Reintroduction stages and achieved \>10kg weight loss

You may not qualify if:

  • People currently participating in another clinical research trial (not including BEYOND Weight Loss study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NHS Lothian

Edinburgh, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

NHS Highland

Inverness, United Kingdom

Location

Related Publications (1)

  • Brosnahan N, Hankey C, Leeds A, Leslie W, Thom G, Hutchison L, Govan L, Ross H, Lean MEJ. Diet strategies for maintaining substantial therapeutic weight loss: 78-week mixed methods randomised trial. Clin Nutr. 2025 Oct;53:188-198. doi: 10.1016/j.clnu.2025.08.009. Epub 2025 Aug 12.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Lean, FRCPS

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 17, 2016

Study Start

April 12, 2016

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations