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Completed

NCT Number: NCT03669887

Lifestyle Modification to Improve Diet in Women With GDM

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.

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Key information

Conditions

Gestational Diabetes Body Weight Childhood Obesity Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hosptial

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Modification Program

Behavioral

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.

Primary outcomes

  1. Proportion achieving body weight goal

    Time frame: 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 outcomes

  1. Change in diabetes risk

    Time frame: Baseline, 12 months

    Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)

  2. Changes in fasting glucose

    Time frame: Baseline, 12 months

    Measured by OGTT (changes in mmol/l)

  3. Changes in physical activity

    Time frame: 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.

  4. Changes in quality of life indices

    Time frame: 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.)

  5. % of achieving dietary intervention goal

    Time frame: Baseline, 8weeks, 12 months

    Measured by a 3-day food intake record

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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