ObesityNCT02683798
BEYOND Weight Loss Maintenance Study
A study testing Continuous energy restriction and Intermittent energy restriction in people with Obesity, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
Trial summary
A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Continuous energy restriction and Intermittent energy restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 12 Apr 2016to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed Counterweight Plus Total Diet Replacement and Food Reintroduction stages and achieved >10kg weight loss
Who cannot join
- People currently participating in another clinical research trial (not including BEYOND Weight Loss study)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
NHS Lothian
Edinburgh
NHS Greater Glasgow and Clyde
Glasgow
NHS Highland
Inverness
About this study
Official title: Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
A study to determine the effectiveness of two weight loss maintenance interventions in Counterweight Plus, a structured weight management programme.
Read the 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.
- Conditions
- Obesity
- Being tested
- Continuous energy restriction, Intermittent energy restriction
- Keywords
- Weight loss maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous energy restrictionDietary supplement
1 x formula food (202-209kcal) meal replacement per day
Intermittent energy restrictionDietary supplement
4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
| Study group | Role | What they receive |
|---|---|---|
| Continuous energy restriction | Active comparator | 1 x formula food (202-209kcal) meal replacement per day Receives: 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 Receives: Dietary Supplement: Intermittent energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Difference between the two groups in change in body weight (kg)
Measured: Baseline, 26 weeks
Secondary outcomes (6)
Weight change
Change in body weight (kg)
Measured: Baseline, 52 weeks, 78 weeks
Acceptability
Number of clinic appointments attended as a proportion of the total number offered
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks
Behavioural strategies
Number of times behaviour change strategies used, assessed by qualitative analysis/coding of consultations
Measured: 78 weeks
Eating behaviours
Change measured using Three Factor Eating Questionnaire- R18 (TFEQ-R18)
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks
Quality of life
Change measured using EuroQoL-5D (EQ-5D)
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks
Cost of interventions
Difference between groups
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start12 Apr 2016
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Michael Lean, FRCPS, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683798
- Sponsor's protocol ID
- GN15HN592
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40934815
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Weight Loss Maintenance Interventions in Counterweight Plus
- ClinicalTrials.gov ID
- NCT02683798
- Acronym / sponsor ID
- GN15HN592
- Conditions
- Obesity
- Keywords
- Weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous energy restriction | Active comparator | Dietary Supplement: Continuous energy restriction1 x formula food (202-209kcal) meal replacement per day |
| Intermittent energy restriction | Experimental | Dietary Supplement: Intermittent energy restriction4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed Counterweight Plus Total Diet Replacement and Food Reintroduction stages and achieved >10kg weight loss
Key exclusion criteria (1 listed)
- People currently participating in another clinical research trial (not including BEYOND Weight Loss study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous energy restriction1 x formula food (202-209kcal) meal replacement per day | Dietary supplement | Continuous energy restriction |
| Intermittent energy restriction4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week | Dietary supplement | Intermittent energy restriction |
Primary outcome
Weight change
Time frame: Baseline, 26 weeks
Difference between the two groups in change in body weight (kg)
6 secondary outcomes
Weight change
Time frame: Baseline, 52 weeks, 78 weeks
Acceptability
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Behavioural strategies
Time frame: 78 weeks
Eating behaviours
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Quality of life
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Cost of interventions
Time frame: 78 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 40934815Brosnahan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lean, FRCPS principal investigator
University of Glasgow
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous energy restriction and Intermittent energy restriction in people with Obesity, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: Baseline, 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02683798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.