Lifestyle Modification to Improve Diet in Women With GDM

NCT03669887 | Completed

• 1 other identifier: 2017.268-T
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Diabetes; Childhood Obesity; Diabetes Mellitus

Keywords

Gestational diabetes; Diabetes; Lifestyle; Diet Modification; Childhood Obesity; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in diabetes risk

  Baseline, 12 months

• Changes in fasting glucose

  Baseline, 12 months

• Changes in physical activity

  Baseline, 12 months

• Changes in quality of life indices

  Baseline, 12 months

• % of achieving dietary intervention goal

  Baseline, 8weeks, 12 months

Study Arms (2)

Lifestyle Modification Program

EXPERIMENTAL

Women randomised into the intervention group received the 1-year lifestyle modification program.

Behavioral: Lifestyle Modification Program

Control

NO INTERVENTION

Women randomised into the control arm received standard postnatal care.

Interventions

Lifestyle Modification Program BEHAVIORAL

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.

Lifestyle Modification Program

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Women had GDM history
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hosptial

Shatin, Hong Kong

Location

Related Publications (6)

• 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.

  PMID: 22179684 BACKGROUND

• 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.

  PMID: 19047239 BACKGROUND

• 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.

  PMID: 28279981 BACKGROUND

• 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.

  PMID: 18070255 BACKGROUND

• 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.

  PMID: 23623998 BACKGROUND

• 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.

  PMID: 21540430 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus; Pediatric Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald C Ma, MBBChir,FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 13, 2018
• Study Start: September 12, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 15, 2022

Record last verified: 2022-02

Locations

HK (1)