Dietary and Lifestyle Interventions in Obese Pregnant Women

Not Applicable

Completed

• Conditions: Obesity; Weight Gain; Lifestyle; Pregnancy Related
• Interventions: Behavioral: Dietary and lifestyle intervention

• Registration Number: NCT02095028
• Lead Sponsor: Capital Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-21
• Last Update Submitted: 2014-03-21
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 373

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary and lifestyle intervention	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

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	From enrollment to delivery (28-34 weeks of gestation)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University; 🇨🇳 Beijing, China