Health After Birth Intervention Trial (HABIT)

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

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: Adapted NHS weight management 1:1 programme; Other: NHS 1:1 weight management programme

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH9 2HL
    • Astley Ainslie Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Adapted NHS weight management 1:1 programme. Low carbohydrate dietary focus, enhanced behaviour change via telehealth, daily step target supported by pedometers	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
Active Comparator: Active comparator NHS 1:1 weight management programme; 12 week NHS 1:1 weight management programme	Other: NHS 1:1 weight management programme; NHS 1:1 weight management programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bodyweight (Kilograms)	Bodyweight measured by the CI or self-reported	Proposed 0,3,6,8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body composition (Fat mass/fat free mass)	Medical grade	Proposed 0,3,6,8 months
Change in Waist circumference (Centimetres)	SECA Ergonomic measuring tape	Proposed 0,3,6,8 months
Change in systolic and diastolic Blood pressure	Standard technique	Proposed 0,3,6,8 months
Change in Physical activity levels	Level of physical activity (minutes) and step count from pedometer data	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	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	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	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	Proposed 0,3,6,8 months
Food frequency questionnaire	Standard validated tool	Baseline
Diet quality	Diet quality measured using a 3 day unweighed food diary	Proposed 0,3,6,8 months

Collaborators and Investigators

• Sponsor: Queen Margaret University
• Collaborators: NHS Lothian
• Investigators: Principal Investigator: Ashleigh Graham, Queen Margaret University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: weight management postpartum
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 10052021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only anonymised data will be accessible by the rest of the current research team for purpose of statistical analysis and monitoring

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No