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Completed

NCT Number: NCT01545934

Preventing Excessive Gestational Weight Gain in Obese Women

The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University, San Luis Obispo, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years old
  • < 16 weeks gestation
  • BMI >= 25
  • Willing to consent

Exclusion criteria

  • Pregnant with Twins
  • Untreated medical or psychological problem
  • Inability to be physically active

Treatment and study plan

Lifestyle Intervention

Behavioral

The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.

Primary outcomes

  1. Weight Gain Per Week of Observation

    Time frame: 13 weeks gestation, 35 weeks gestation

    Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.

Secondary outcomes

  1. Offspring Weight Gain

    Time frame: 1 week, 6 months, 12 months

    Offspring weight for age z scores from birth (1 week), to 6 months, and 12 months of age.

  2. Kcals/Day

    Time frame: 13 weeks gestation, 34 weeks gestation

    Changes in maternal calorie intake (Kcal/day)

  3. Changes in Offspring Dietary Intake

    Time frame: 1 week, 6 months, 12 months

    Changes in offspring intake of breast milk (#feeds per day) and/or formula (#feeds per day).

  4. Changes in Maternal Glucose

    Time frame: 13 weeks gestation, 34 weeks gestation

    Fasting glucose

  5. Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.

    Time frame: 13 weeks, 40 weeks

    Self-reported pre-pregnancy weight will be subtracted from weight measured at last clinic visit prior to delivery. Women will be categorized as exceeding 2009 IOM guidelines if the difference is > 11.5 kg gain for women with prepregnancy overweight or >9 kg for women with prepregnancy obesity.

  6. Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group

    Time frame: 48-56 weeks post delivery

    Weight measured at 48-56 weeks postpartum and subtracted from self-reported prepregnancy weight and then categorized as at or below vs. above self-reported prepregnancy weight.

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

  • Brown University

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
Mar 7, 2012
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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