Lifestyle Modification to Improve Diet in Women With GDM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gestational Diabetes Diabetes Childhood Obesity Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Lifestyle Modification Program

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

Group Type EXPERIMENTAL

Lifestyle Modification Program

Intervention Type 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.

Control

Women randomised into the control arm received standard postnatal care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No