NCT05137691

Health After Birth Intervention Trial

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Queen Margaret University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
OTHER	NHS 1:1 weight management programme	NHS 1:1 weight management programme

Timeline

• Start date: 2022-05-19
• Primary completion: 2022-09-15
• Completion: 2022-09-15
• First posted: 2021-11-30
• Last updated: 2022-10-21

Locations

1 site across 1 country: United Kingdom