Back to resultsLifestyle Modification to Improve Diet in Women With GDM
Primary Purpose
Gestational Diabetes, Diabetes, Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Lifestyle Modification Program
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes focused on measuring Gestational diabetes, Diabetes, Lifestyle, Diet Modification, Childhood Obesity, Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Modification Program
Control
Arm Description
Women randomised into the intervention group received the 1-year lifestyle modification program.
Women randomised into the control arm received standard postnatal care.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in diabetes risk
Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)
Changes in fasting glucose
Measured by OGTT (changes in mmol/l)
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.
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.)
% of achieving dietary intervention goal
Measured by a 3-day food intake record
Full Information
NCT ID
NCT03669887
First Posted
September 12, 2018
Last Updated
February 28, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03669887
Brief Title
Lifestyle Modification to Improve Diet in Women With GDM
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Diabetes, Childhood Obesity, Diabetes Mellitus
Keywords
Gestational diabetes, Diabetes, Lifestyle, Diet Modification, Childhood Obesity, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Modification Program
Arm Type
Experimental
Arm Description
Women randomised into the intervention group received the 1-year lifestyle modification program.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Women randomised into the control arm received standard postnatal care.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification Program
Intervention Description
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 Outcome Measure Information:
Title
Proportion achieving body weight goal
Description
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
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in diabetes risk
Description
Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)
Time Frame
Baseline, 12 months
Title
Changes in fasting glucose
Description
Measured by OGTT (changes in mmol/l)
Time Frame
Baseline, 12 months
Title
Changes in physical activity
Description
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.
Time Frame
Baseline, 12 months
Title
Changes in quality of life indices
Description
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.)
Time Frame
Baseline, 12 months
Title
% of achieving dietary intervention goal
Description
Measured by a 3-day food intake record
Time Frame
Baseline, 8weeks, 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women had GDM history
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald C Ma, MBBChir,FRCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hosptial
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will decide on whether to make data available based on study results and the requests received.
Citations:
PubMed Identifier
22179684
Citation
Tam WH, Ma RC, Yang X, Ko GT, Lao TT, Chan MH, Lam CW, Cockram CS, Chan JC. Cardiometabolic risk in Chinese women with prior gestational diabetes: a 15-year follow-up study. Gynecol Obstet Invest. 2012;73(2):168-76. doi: 10.1159/000329339. Epub 2011 Dec 16.
Results Reference
background
PubMed Identifier
19047239
Citation
Tam WH, Ma RC, Yang X, Ko GT, Tong PC, Cockram CS, Sahota DS, Rogers MS, Chan JC. Glucose intolerance and cardiometabolic risk in children exposed to maternal gestational diabetes mellitus in utero. Pediatrics. 2008 Dec;122(6):1229-34. doi: 10.1542/peds.2008-0158.
Results Reference
background
PubMed Identifier
28279981
Citation
Tam WH, Ma RCW, Ozaki R, Li AM, Chan MHM, Yuen LY, Lao TTH, Yang X, Ho CS, Tutino GE, Chan JCN. In Utero Exposure to Maternal Hyperglycemia Increases Childhood Cardiometabolic Risk in Offspring. Diabetes Care. 2017 May;40(5):679-686. doi: 10.2337/dc16-2397. Epub 2017 Mar 9.
Results Reference
background
PubMed Identifier
18070255
Citation
Woo J, Sea MM, Tong P, Ko GT, Lee Z, Chan J, Chow FC. Effectiveness of a lifestyle modification programme in weight maintenance in obese subjects after cessation of treatment with Orlistat. J Eval Clin Pract. 2007 Dec;13(6):853-9. doi: 10.1111/j.1365-2753.2006.00758.x.
Results Reference
background
PubMed Identifier
23623998
Citation
Wong VW, Chan RS, Wong GL, Cheung BH, Chu WC, Yeung DK, Chim AM, Lai JW, Li LS, Sea MM, Chan FK, Sung JJ, Woo J, Chan HL. Community-based lifestyle modification programme for non-alcoholic fatty liver disease: a randomized controlled trial. J Hepatol. 2013 Sep;59(3):536-42. doi: 10.1016/j.jhep.2013.04.013. Epub 2013 Apr 23.
Results Reference
background
PubMed Identifier
21540430
Citation
Ferrara A, Hedderson MM, Albright CL, Ehrlich SF, Quesenberry CP Jr, Peng T, Feng J, Ching J, Crites Y. A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial. Diabetes Care. 2011 Jul;34(7):1519-25. doi: 10.2337/dc10-2221. Epub 2011 May 3.
Results Reference
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Lifestyle Modification to Improve Diet in Women With GDM
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