Lifestyle Modification to Improve Diet in Women With GDM

Not Applicable

Completed

• Conditions: Gestational Diabetes; Diabetes Mellitus; Diabetes; Childhood Obesity
• Interventions: Behavioral: Lifestyle Modification Program

• Registration Number: NCT03669887
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Study Timeline

• Study Start: 2018-09-12
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

1. Women who developed gestational diabetes in their most recent pregnancy
2. GDM is diagnosed according to the WHO 2013 criteria of FBG ≥ 5.1mmol/l, or 1 hour glucose ≥10.0mmol/l, or 2 hour glucose ≥ 8.5mmol/l during 75g OGTT performed at 24-28 weeks of pregnancy
3. Singleton pregnancy
4. Reside normally in Hong Kong
5. Able to communicate in Chinese
6. Willing to give consent and follow study procedures

Exclusion Criteria

1. Subjects with pre-existing diabetes (T1D or T2D)
2. Subjects with life-threatening conditions including malignancy that is not in remission
3. Subjects with known psychiatric conditions including depression
4. Substance abuse or use of illicit substances
5. Subjects with significant renal impairment (eGFR<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy)
6. Subjects on chronic corticosteroids treatment
7. Subjects with known myocardial infarction within the preceding 3 months
8. Major physical disability
9. Participation in other intervention trials
10. Surgical or medical interventions to treat obesity
11. Pregnancy at any point during the intervention period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Modification Program	Lifestyle Modification Program	Women randomised into the intervention group received the 1-year lifestyle modification program.

Primary Outcome Measures

Name	Time	Method
Proportion achieving body weight goal	Baseline, 12 months	3% body weight change at 12 months if pre-pregnant BMI ≥ 23kg/m2, or for those with pre-pregnant BMI \<23 kg/m2, either back to pre-pregnant weight or maintaining within BMI \<23 kg/m2

Secondary Outcome Measures

Name	Time	Method
Change in diabetes risk	Baseline, 12 months	Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)
Changes in fasting glucose	Baseline, 12 months	Measured by OGTT (changes in mmol/l)
Changes in physical activity	Baseline, 12 months	Measured by International Physical Activity Questionnaires (IPAQ) Total 7 questions on physical activity frequency according to intensity of the physical activity. Higher score indicates more physical activity.
Changes in quality of life indices	Baseline, 12 months	Measured by Patient Health Questionnaire (PHQ-9) total score 27. Higher score indicates greater severity of depression. (Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.)
% of achieving dietary intervention goal	Baseline, 8weeks, 12 months	Measured by a 3-day food intake record

Trial Locations

Locations (1)

Prince of Wales Hosptial; 🇭🇰 Shatin, Hong Kong