Clinical trial NCT03669887: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Diabetes
Childhood Obesity
Diabetes Mellitus
Keywords: Gestational diabetes
Diabetes
Lifestyle
Diet Modification
Childhood Obesity
Diabetes Mellitus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2018-09-13
Enrollment: 103
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportion achieving body weight goal
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in diabetes risk
timeFrame: Baseline, 12 months
measure: Changes in fasting glucose
timeFrame: Baseline, 12 months
measure: Changes in physical activity
timeFrame: Baseline, 12 months
measure: Changes in quality of life indices
timeFrame: Baseline, 12 months
measure: % of achieving dietary intervention goal
timeFrame: Baseline, 8weeks, 12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hosptial
Study officials:
affiliation: Chinese University of Hong Kong
name: Ronald C Ma, MBBChir,FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.