Health After Birth Intervention Trial

NCT ID: NCT05137691

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2022-09-15

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental

Adapted NHS weight management 1:1 programme. Low carbohydrate dietary focus, enhanced behaviour change via telehealth, daily step target supported by pedometers

Group Type: EXPERIMENTAL

Adapted NHS weight management 1:1 programme

Intervention Type: OTHER

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 NHS 1:1 weight management programme

12 week NHS 1:1 weight management programme

Group Type: ACTIVE_COMPARATOR

NHS 1:1 weight management programme

Intervention Type: OTHER

NHS 1:1 weight management programme

Interventions

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

Intervention Type: OTHER

NHS 1:1 weight management programme

NHS 1:1 weight management programme

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

Queen Margaret University

OTHER

Sponsor Role: lead

Responsible Party

Ashleigh Graham

Senior Practitioner in clinical research and Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashleigh Graham

Role: PRINCIPAL_INVESTIGATOR

Queen Margaret University

Locations

Astley Ainslie Hospital

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

10052021

Identifier Type: -

Identifier Source: org_study_id