Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01084941
First received: March 9, 2010
Last updated: November 20, 2013
Last verified: July 2013

March 9, 2010
November 20, 2013
April 2010
December 2012   (final data collection date for primary outcome measure)
The primary outcome is whether a woman's weight gain follows the Institute of Medicine's recommendations for pregnancy weight gain. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01084941 on ClinicalTrials.gov Archive Site
  • To compare the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation and after delivery between women in the lifestyle intervention group and women receiving standard care. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • To explore the impact of the lifestyle intervention in preventing maternal and fetal complications between women in the lifestyle intervention group and women receiving standard care. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women
Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women

The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight and obesity when they become pregnant, experience higher rates of excessive weight gain during pregnancy, and experience higher rates of maternal and neonatal complications after adjusting for sociodemographic characteristics and comorbidities than Caucasian women. Epidemiologic studies indicate that lifestyle modification programs based on diet and exercise are promising approaches in controlling weight gain as well as in preventing type 2 diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet and moderate exercise will result in higher compliance with Institute of Medicine guidelines for weight gain than women receiving standard care. Such lifestyle modifications should reduce risk of maternal and neonatal complications. We propose 1) to determine whether a lifestyle intervention program, based on diet and moderate physical activity implemented shortly after first recognition of pregnancy, will result in higher compliance with Institute of Medicine guidelines for weight gain compared to women receiving standard care; 2) to determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the lifestyle intervention group and women receiving standard care; and 3) to explore the impact of the lifestyle intervention on the development of maternal and fetal complications during pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent the burden of obesity-related complications during pregnancy and reduce risk of subsequently developing overt diabetes.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pregnancy
  • Weight Gain
  • Behavioral: Lifestyle Intervention group
    Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.
  • Behavioral: Standard of Care
    Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.
  • Experimental: Lifestyle intervention
    Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.
    Intervention: Behavioral: Lifestyle Intervention group
  • Active Comparator: Standard of care group
    Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.
    Intervention: Behavioral: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Blacks and Hispanic
  • women between 18-45 years of age;
  • 2) overweight and obese (BMI > 25 kg/m2),
  • 3) have a sedentary lifestyle (<30 minutes/day of moderate physical activity), and
  • 4) prenatal care established at less than 20 weeks of gestation,
  • 5) with a singleton pregnancy.

Exclusion Criteria:

  • Women with 1) age < 18 or > 45 years,
  • 2) > 20 weeks gestation,
  • 3) history of diagnosis of type 2 diabetes, hypertension, cardiovascular disease, chronic renal disease, and active liver disease (AST > 3 ULN),
  • 4) anemia (hemoglobin < 10 g, hematocrit < 32%);
  • 5) current medications which adversely influence glucose tolerance (corticosteroids),
  • 6) multiple pregnancy,
  • 7) women not planning to continue pregnancy to term, 7) contraindications to participate in regular physical activity,
  • 8) patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01084941
IRB00030742
Yes
Guillermo Umpierrez, Emory University
Guillermo Umpierrez
Not Provided
Principal Investigator: Guillermo Umpierrez, MD Emory University
Emory University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP