Dietary and Lifestyle Interventions in Obese Pregnant Women

March 21, 2014 updated by: Guanghui Li, Capital Medical University

Effects of Dietary and Lifestyle Interventions in Obese Pregnant Women From the First Trimester on Gestational Weight Gain and Pregnancy Outcomes

Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.

Objective: This study examined whether intensive dietary and lifestyle interventions initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy outcomes in Chinese obese pregnant women.

Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of gestation.The sample size was estimated using GWG reduction as the primary outcome variable. The investigators pilot study (data not published) showed the gestational weight gain was 12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up during pregnancy, the total sample size required was 136 women in intervention group and 68 in control group(standard care group). Participants were randomly assigned to the control or the intervention group. The intervention focused on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian section.

Hypothesis:The intensive dietary and lifestyle intervention performed from the first trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100026
        • Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • gestational age between 6 and 12 weeks of gestation, pre-pregnancy≥28 (kg/m2)
  • age ≥18 years, and a singleton pregnancy.

Exclusion Criteria:

  • patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
  • gestational weeks ≥ 13
  • age <18 years
  • multiple pregnancy
  • uterine malformation
  • or physical restriction that prevents exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary and lifestyle intervention
Intervention group:Based on standard care,intensive dietary and lifestyle intervention was provided. Initiated from the first trimester to delivery,every 2-4 weeks follow-up
Behavioral: Dietary and lifestyle intervention
participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
No Intervention: Standard care group
Standard care group:Participants received one group session in which prenatal general dietary, nutrition guideline, physical activity and recommendation for gestational weight gain introduced by a registered dietitian in 1.5hours.Participants received their regularly scheduled visits without additional dietary and lifestyle follow-up and guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gestational weight gain
Time Frame: From enrollment to delivery (28-34 weeks of gestation)
From enrollment to delivery (28-34 weeks of gestation)

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of gestational diabetes mellitus
Time Frame: From enrollment to delivery (28-34 weeks of gestation)
From enrollment to delivery (28-34 weeks of gestation)
The incidence of hypertensive disorders during pregnancy
Time Frame: From enrollment to delivery (28-34 weeks of gestation)
From enrollment to delivery (28-34 weeks of gestation)
The incidence of large-for-gestational-age infants
Time Frame: From enrollment to delivery(28-34 weeks of gestation)
From enrollment to delivery(28-34 weeks of gestation)
The incidence of macrosomia infants
Time Frame: From enrollment to delivery (28-34 weeks of gestation)
From enrollment to delivery (28-34 weeks of gestation)
The rate of caesarian section
Time Frame: From enrollment to delivery(28-34 weeks of gestation)
From enrollment to delivery(28-34 weeks of gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Collaborators

Ministry of Health, China

Investigators

  • Principal Investigator: Guanghui Li, MD,PhD, Beijing Obstetrics and Gynecology Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 24, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2014

Last Update Submitted That Met QC Criteria

March 21, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-2011-02
  • 201002013 (Other Identifier: Health industry special funds for Public Benefit)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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