Lifestyle Modification to Improve Diet in Women With GDM

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669887
• Other study ID #: 2017.268-T
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hosptial	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Prince of Wales Hospital, Shatin, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in diabetes risk	Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)	Baseline, 12 months
Secondary	Changes in fasting glucose	Measured by OGTT (changes in mmol/l)	Baseline, 12 months
Secondary	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
Secondary	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
Secondary	% of achieving dietary intervention goal	Measured by a 3-day food intake record	Baseline, 8weeks, 12 months