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Lifestyle Modification to Improve Diet in Women With GDM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669887
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
Prince of Wales Hospital, Shatin, Hong Kong
Information provided by (Responsible Party):
Professor Ronald C.W. Ma, 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Diabetes Childhood Obesity Diabetes Mellitus Behavioral: Lifestyle Modification Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle Modification Program 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.

No Intervention: Control



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women had GDM history
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669887


Contacts
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Contact: Ronald C Ma, MBBChir,FRCP 35053594 rcwma@cuhk.edu.hk
Contact: Kit Tsoi, MSc kit.tsoi@link.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hosptial Recruiting
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Investigators
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Principal Investigator: Ronald C Ma, MBBChir,FRCP Chinese University of Hong Kong
Publications:
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Responsible Party: Professor Ronald C.W. Ma, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03669887    
Other Study ID Numbers: 2017.268-T
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will decide on whether to make data available based on study results and the requests received.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Ronald C.W. Ma, Chinese University of Hong Kong:
Gestational diabetes
Diabetes
Lifestyle
Diet Modification
Childhood Obesity
Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Pregnancy Complications