Lifestyle Modification to Improve Diet in Women With GDM

Chinese University of Hong Kong103 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

103

Conditions

Gestational Diabetes Diabetes Childhood Obesity Diabetes Mellitus

Interventions

Lifestyle Modification ProgramBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hosptial

Shatin, Hong Kong

Outcomes

Primary Outcomes

Proportion achieving body weight goal

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