Lifestyle Modification to Improve Diet in Women With GDM

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gestational Diabetes, Diabetes, Childhood Obesity, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Lifestyle Modification Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who developed gestational diabetes in their most recent pregnancy 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 Singleton pregnancy Reside normally in Hong Kong Able to communicate in Chinese Willing to give consent and follow study procedures Exclusion Criteria: Subjects with pre-existing diabetes (T1D or T2D) Subjects with life-threatening conditions including malignancy that is not in remission Subjects with known psychiatric conditions including depression Substance abuse or use of illicit substances Subjects with significant renal impairment (eGFR<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy) Subjects on chronic corticosteroids treatment Subjects with known myocardial infarction within the preceding 3 months Major physical disability Participation in other intervention trials Surgical or medical interventions to treat obesity Pregnancy at any point during the intervention period

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the pilot study that preceded a similar postpartum intervention trial, in which the intervention included telephone counselling (Ferrara et al. 2011). The proportion of women from the control arm who reached the postpartum weight goal was 30%, with the absolute difference in percentage of women meeting the postpartum weight goals being 16% between the intervention and control arms. Assuming a larger between group difference of 20% based on our more intensive individual-level intervention, and a similar 30% of women in the control arm reaching postpartum weight goal, a sample size of 220 (110 in each arm) would give 90% power to detect the between group difference of 20%. Allowing for up to 30% drop-out at 12 months, we planned to recruit 157 subjects in each arm (total sample size n=314).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Modification Program<br>Women randomised into the intervention group received the 1-year lifestyle modification program. | Behavioral: Lifestyle Modification Program<br>* 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.<br>|
| No Intervention: Control<br>Women randomised into the control arm received standard postnatal care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diabetes risk | Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself) | Baseline, 12 months | 
| Changes in fasting glucose | Measured by OGTT (changes in mmol/l) | Baseline, 12 months | 
| Changes in physical activity | 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. | Baseline, 12 months | 
| Changes in quality of life indices | 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.) | Baseline, 12 months | 
| % of achieving dietary intervention goal | Measured by a 3-day food intake record | Baseline, 8weeks, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, Diabetes, Lifestyle, Diet Modification, Childhood Obesity, Diabetes Mellitus