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Lifestyle Modification to Improve Diet in Women With GDM

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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

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE September 12, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
Proportion achieving body weight goal [ Time Frame: Baseline, 12 months ]
3% body weight reduction 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Change in diabetes risk [ Time Frame: Baseline, 12 months ]
    Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)
  • Changes in fasting glucose [ Time Frame: Baseline, 12 months ]
    Measured by OGTT (changes in mmol/l)
  • 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.
  • 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.)
  • % of achieving dietary intervention goal [ Time Frame: Baseline, 8weeks, 12 months ]
    Measured by a 3-day food intake record
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • Change in diabetes risk [ Time Frame: Baseline, 12 months ]
    Measured by a validated risk score calculator
  • Changes in fasting glucose [ Time Frame: Baseline, 12 months ]
    Measured by OGTT
  • Changes in physical activity [ Time Frame: Baseline, 12 months ]
    Measured by International Physical Activity Questionnaires (IPAQ)
  • Changes in quality of life indices [ Time Frame: Baseline, 12 months ]
    Measured by Patient Health Questionnaire (PHQ-9)
  • % of achieving dietary intervention goal [ Time Frame: Baseline, 8weeks, 12 months ]
    Measured by a 3-day food intake record
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Modification to Improve Diet in Women With GDM
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Gestational Diabetes
  • Diabetes
  • Childhood Obesity
  • Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Lifestyle Modification Program
    Intervention: Behavioral: Lifestyle Modification Program
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
317
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women had GDM history
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ronald C Ma, MBBChir,FRCP 35053594 rcwma@cuhk.edu.hk
Contact: Kit Tsoi, MSc kit.tsoi@link.cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03669887
Other Study ID Numbers  ICMJE 2017.268-T
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We will decide on whether to make data available based on study results and the requests received.
Responsible Party Professor Ronald C.W. Ma, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Prince of Wales Hospital, Shatin, Hong Kong
Investigators  ICMJE
Principal Investigator: Ronald C Ma, MBBChir,FRCP Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP