Health After Birth Intervention Trial

Obesity Clinical Trial

— HABIT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05137691
• Other study ID #: 10052021
• Status: Terminated
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: October 2022
• Source: Queen Margaret University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 on specified health outcomes amongst post-partum women living with obesity

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Adapted NHS weight management 1:1 programme
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 programme
NHS 1:1 weight management programme

Locations

Country	Name	City	State
United Kingdom	Astley Ainslie Hospital	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
Queen Margaret University	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bodyweight (Kilograms)	Bodyweight measured by the CI or self-reported	Proposed 0,3,6,8 months
Secondary	Change in Body composition (Fat mass/fat free mass)	Medical grade	Proposed 0,3,6,8 months
Secondary	Change in Waist circumference (Centimetres)	SECA Ergonomic measuring tape	Proposed 0,3,6,8 months
Secondary	Change in systolic and diastolic Blood pressure	Standard technique	Proposed 0,3,6,8 months
Secondary	Change in Physical activity levels	Level of physical activity (minutes) and step count from pedometer data	Proposed 0,3,6,8 months
Secondary	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	0,3,6,8 months
Secondary	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	0,3,6,8 months
Secondary	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	Baseline, post-intervention at 3 months
Secondary	Change in Quality of life	Measured using the World Health Organisation Quality of life (BREF) tool. A lower score is less favourable	Proposed 0,3,6,8 months
Secondary	Food frequency questionnaire	Standard validated tool	Baseline
Secondary	Diet quality	Diet quality measured using a 3 day unweighed food diary	Proposed 0,3,6,8 months