ObesityHABITNCT05137691
Health After Birth Intervention Trial
A study testing Adapted NHS weight management 1:1 programme and NHS 1:1 weight management programme in people with Obesity, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
This trial is to assess the feasibility of a larger, definitive RCT and determine the clinical effectiveness of an NHS 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per Feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adapted NHS weight management 1:1 programme and NHS 1:1 weight management programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2022to 15 Sep 2022
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged 18 or above
- Ready and motivated to make lifestyle changes
- Have a Body Mass Index of ≥30 kg/m2 (at initial booking appointment)
- Additional study specific criteria
- English speaking and ability to read English language
- Capacity to consent to participating in the study
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- Are non-diabetic or those with Type 2 diabetes which is diet controlled
- Deemed medically fit by GP/medical professional to participate via email
- Have recently given birth (within 1 year)
- Are not receiving weight management support elsewhere e.g. NHS, Scottish slimmers, weight watchers
- Have access to a mobile phone and weighing scales
Who cannot join
- Have uncontrolled hypothyroidism
- Have unstable psychosis or severe and unstable personality disorder
- Are pregnant
- Have dementia
- Have moderate to severe learning disability or learning difficulty which impairs the ability to adhere to the programme (identified by medical history and confirmed with GP)
- Current alcohol or substance misuse (6 month period of abstinence)
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- Active purging
- Bulimia Nervosa
- Binge Eating Disorder
- Additional study specific criteria
- Known cancers
- Type 1 Diabetes or Type 2 Diabetes on any Diabetic medication (including Insulin)
- Have a pacemaker
- Renal impairment
- Taking Orlistat or any other weight loss medication or had previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility RCT Investigating the Effect of a Kilocalorie Controlled, Low Carbohydrate Dietary Intervention, Behavioural Modification and Telehealth vs a Standard 1:1 NHS Weight Management Programme in Post-partum Women Living With Obesity
This trial is to assess the feasibility of a larger, definitive RCT and determine the clinical effectiveness of an NHS 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per Feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change on specified health outcomes amongst post-partum women living with obesity
Read the detailed description
For individuals living with obesity, the post-partum period is currently the initial, optimal timeframe for weight management. Many women reconceive during the post-partum phase, increasing the risk of between-pregnancy bodyweight retention and even gain. Consequentially, many re-enter subsequent pregnancies with a higher BMI often associated with unfavourable obstetric outcome and further cyclical perpetuation.
Health behaviour change is an important facet within weight management interventions and delivery may be enhanced by digital technologies, for example, telehealth. Short messaging service (SMS) may be used to enhance communication between patients and practitioner and is relatively inexpensive to use.
Low carbohydrate diets continue to gain traction however research is arguably confounded by the lack of a universally agreed definition and classification. Feinman and colleagues (2015) propose intermediary categories. The experimental arm of this trial will be encouraged to adopt a non-ketogenic LCD as per Feinman.
- Conditions
- Obesity
- Being tested
- Adapted NHS weight management 1:1 programme, NHS 1:1 weight management programme
- Keywords
- weight management postpartum
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted NHS weight management 1:1 programmeOther
Adapted NHS 1:1 weight management programme with a low carbohydrate dietary focus, incorporating enhanced behaviour change via telehealth, step count and pedometer
NHS 1:1 weight management programmeOther
NHS 1:1 weight management programme
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Adapted NHS weight management 1:1 programme. Low carbohydrate dietary focus, enhanced behaviour change via telehealth, daily step target supported by pedometers Receives: Other: Adapted NHS weight management 1:1 programme |
| Active comparator NHS 1:1 weight management programme | Active comparator | 12 week NHS 1:1 weight management programme Receives: Other: NHS 1:1 weight management programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bodyweight (Kilograms)
Bodyweight measured by the CI or self-reported
Measured: Proposed 0,3,6,8 months
Secondary outcomes (10)
Change in Body composition (Fat mass/fat free mass)
Medical grade
Measured: Proposed 0,3,6,8 months
Change in Waist circumference (Centimetres)
SECA Ergonomic measuring tape
Measured: Proposed 0,3,6,8 months
Change in systolic and diastolic Blood pressure
Standard technique
Measured: Proposed 0,3,6,8 months
Change in Physical activity levels
Level of physical activity (minutes) and step count from pedometer data
Measured: Proposed 0,3,6,8 months
Change in emotional eating using the Weight loss Readiness Test II
Incidence of emotional eating (if present) determined by change score. Increased score is less favourable
Measured: 0,3,6,8 months
Change in hunger and eating cues using the Weight loss Readiness Test II
Hunger and eating cues determined by change score. Increased score is less favourable
Measured: 0,3,6,8 months
Change in psychological distress (if present) using the Clinical Outcomes in Routine Evaluation-10 screening tool
Measured using the Clinical Outcomes in Routine Evaluation-10 tool using change scores. An increased score is less favourable
Measured: Baseline, post-intervention at 3 months
Change in Quality of life
Measured using the World Health Organisation Quality of life (BREF) tool. A lower score is less favourable
Measured: Proposed 0,3,6,8 months
Food frequency questionnaire
Standard validated tool
Measured: Baseline
Diet quality
Diet quality measured using a 3 day unweighed food diary
Measured: Proposed 0,3,6,8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start19 May 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Principal investigator, Ashleigh Graham, Queen Margaret University
- Investigators
- Ashleigh Graham, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137691
- Sponsor's protocol ID
- 10052021
- Acronym
- HABIT
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised data will be accessible by the rest of the current research team for purpose of statistical analysis and monitoring
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility RCT Investigating the Effect of a Kilocalorie Controlled, Low Carbohydrate Dietary Intervention, Behavioural Modification and Telehealth vs a Standard 1:1 NHS Weight Management Programme in Post-partum Women Living With Obesity
- ClinicalTrials.gov ID
- NCT05137691
- Acronym / sponsor ID
- HABIT / 10052021
- Conditions
- Obesity
- Keywords
- weight management postpartum
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 19 May 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 30 Nov 2021 (actual)
- 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.
This trial is to assess the feasibility of a larger, definitive RCT and determine the clinical effectiveness of an NHS 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per Feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change on specified health outcomes amongst post-partum women living with obesity
Detailed description
For individuals living with obesity, the post-partum period is currently the initial, optimal timeframe for weight management. Many women reconceive during the post-partum phase, increasing the risk of between-pregnancy bodyweight retention and even gain. Consequentially, many re-enter subsequent pregnancies with a higher BMI often associated with unfavourable obstetric outcome and further cyclical perpetuation.
Health behaviour change is an important facet within weight management interventions and delivery may be enhanced by digital technologies, for example, telehealth. Short messaging service (SMS) may be used to enhance communication between patients and practitioner and is relatively inexpensive to use.
Low carbohydrate diets continue to gain traction however research is arguably confounded by the lack of a universally agreed definition and classification. Feinman and colleagues (2015) propose intermediary categories. The experimental arm of this trial will be encouraged to adopt a non-ketogenic LCD as per Feinman.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Adapted NHS weight management 1:1 programmeAdapted NHS weight management 1:1 programme. Low carbohydrate dietary focus, enhanced behaviour change via telehealth, daily step target supported by pedometers |
| Active comparator NHS 1:1 weight management programme | Active comparator | Other: NHS 1:1 weight management programme12 week NHS 1:1 weight management programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult aged 18 or above
- Ready and motivated to make lifestyle changes
- Have a Body Mass Index of ≥30 kg/m2 (at initial booking appointment)
- Additional study specific criteria
- English speaking and ability to read English language
Key exclusion criteria (15 listed)
- Have uncontrolled hypothyroidism
- Have unstable psychosis or severe and unstable personality disorder
- Are pregnant
- Have dementia
- Have moderate to severe learning disability or learning difficulty which impairs the ability to adhere to the programme (identified by medical history and confirmed with GP)
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 |
|---|---|---|
| Adapted NHS weight management 1:1 programmeAdapted NHS 1:1 weight management programme with a low carbohydrate dietary focus, incorporating enhanced behaviour change via telehealth, step count and pedometer | Other | Experimental |
| NHS 1:1 weight management programmeNHS 1:1 weight management programme | Other | Active comparator NHS 1:1 weight management programme |
Primary outcome
Change in Bodyweight (Kilograms)
Time frame: Proposed 0,3,6,8 months
Bodyweight measured by the CI or self-reported
10 secondary outcomes
Change in Body composition (Fat mass/fat free mass)
Time frame: Proposed 0,3,6,8 months
Change in Waist circumference (Centimetres)
Time frame: Proposed 0,3,6,8 months
Change in systolic and diastolic Blood pressure
Time frame: Proposed 0,3,6,8 months
Change in Physical activity levels
Time frame: Proposed 0,3,6,8 months
Change in emotional eating using the Weight loss Readiness Test II
Time frame: 0,3,6,8 months
Change in hunger and eating cues using the Weight loss Readiness Test II
Time frame: 0,3,6,8 months
Change in psychological distress (if present) using the Clinical Outcomes in Routine Evaluation-10 screening tool
Time frame: Baseline, post-intervention at 3 months
Change in Quality of life
Time frame: Proposed 0,3,6,8 months
Food frequency questionnaire
Time frame: Baseline
Diet quality
Time frame: Proposed 0,3,6,8 months
Results and safety
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No. Only anonymised data will be accessible by the rest of the current research team for purpose of statistical analysis and monitoring
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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.
Ashleigh Graham principal investigator
Queen Margaret University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted NHS weight management 1:1 programme and NHS 1:1 weight management programme in people with Obesity, run by Queen Margaret University at 1 site 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
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?
Change in Bodyweight (Kilograms) (time frame: Proposed 0,3,6,8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2022.