Health After Birth Intervention Trial

NCT05137691 | Terminated

• 1 other identifier: 10052021
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obesity

Keywords

weight management postpartum

Outcome Measures

Primary Outcomes (1)

• Change in Bodyweight (Kilograms)

  Bodyweight measured by the CI or self-reported

  Proposed 0,3,6,8 months

Secondary Outcomes (10)

• Change in Body composition (Fat mass/fat free mass)

  Proposed 0,3,6,8 months

• Change in Waist circumference (Centimetres)

  Proposed 0,3,6,8 months

• Change in systolic and diastolic Blood pressure

  Proposed 0,3,6,8 months

• Change in Physical activity levels

  Proposed 0,3,6,8 months

• Change in emotional eating using the Weight loss Readiness Test II

  0,3,6,8 months

Study Arms (2)

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

Active comparator NHS 1:1 weight management programme

ACTIVE COMPARATOR

12 week NHS 1:1 weight management programme

Other: NHS 1:1 weight management programme

Interventions

Adapted NHS weight management 1:1 programme OTHER

Adapted NHS 1:1 weight management programme with a low carbohydrate dietary focus, incorporating enhanced behaviour change via telehealth, step count and pedometer

Experimental

NHS 1:1 weight management programme OTHER

NHS 1:1 weight management programme

Active comparator NHS 1:1 weight management programme

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Margaret University: lead
• NHS Lothian: collaborator

Study Sites (1)

Astley Ainslie Hospital

Edinburgh, EH9 2HL, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashleigh Graham

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Practitioner in clinical research and Principal investigator

Model Details: Feasibility Randomised Controlled Trial

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 30, 2021
• Study Start: May 19, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)