NCT03669887

Lifestyle Modification to Improve Diet in Women With GDM

A Randomized Clinical Trial Using a Postnatal Lifestyle Modification Program to Improve Diet, Adiposity and Metabolic Outcome in Mothers With Gestational Diabetes and Their Offspring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The study aims to adapt a lifestyle modification program to engage GDM women early in the postnatal period to evaluate its effectiveness in reducing adiposity and metabolic parameters in the mother. Women will be randomized to receive a structured intervention or standard care.

Detailed description

A complex intervention based on a proven lifestyle modification program (LMP) will be delivered to participants randomized to the intervention arm, starting in the early postnatal period. The intervention will consist of individualized face-to-face counseling on diet and weight management, meeting with exercise instructor, followed by telephone contact. Control will receive standard postnatal education materials and usual care provided by government health service.

Conditions

• Gestational Diabetes
• Diabetes
• Childhood Obesity
• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Modification Program	The intervention will consist of 5 individual face-to-face sessions at 2-weekly intervals with a dietitian with experience in lifestyle modification program, followed by monthly phone contact and smartphone text messages. All study participants in the intervention arm will also be arranged to meet with an exercise instructor at least once during the LMP on the same day as one of the dietitian appointment. Ongoing support from the exercise instructor will also be available by phone calls or emails.

Timeline

• Start date: 2018-09-12
• Primary completion: 2020-09-30
• Completion: 2020-12-30
• First posted: 2018-09-13
• Last updated: 2022-03-15

Locations

1 site across 1 country: Hong Kong