Interventions to Reduce Excess Weight Gain in Pregnancy

NCT01643356 | Completed

• 1 other identifier: 10203 Tufts
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.

Conditions

Overweight and Obesity; Pregnancy

Keywords

weight; pregnancy; behavioral intervention; obesity

Outcome Measures

Primary Outcomes (1)

• Maternal and Infant Body Weight Change

  * Maternal non-fasting weight measured at all prenatal clinic and study visits. * Infant weight measured at birth and all pediatric clinic visits through 1 year.

  From first trimester through 1 year post-partum

Secondary Outcomes (2)

• Infant Outcomes

  From birth through first year

• Maternal and Perinatal Outcomes

  First trimester through 1 year post-partum

Study Arms (3)

Fiber Cereal

ACTIVE COMPARATOR

Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger.

Behavioral: Intervention to reduce excess weight gain during pregnancy

Control Group

NO INTERVENTION

Women assigned to this arm of the study will receive routine clinical care and no additional interventions.

Resistant Starch

ACTIVE COMPARATOR

Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger

Behavioral: Intervention to reduce excess weight gain during pregnancy

Interventions

Intervention to reduce excess weight gain during pregnancy BEHAVIORAL

Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.

Fiber Cereal; Resistant Starch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years
• In first trimester of pregnancy
• Must be willing to not join any other weight control program while in the study
• BMI of 25-40 kg/m2
• Willingness and ability to attend support group meetings either in person or via web
• Must be able to read, speak, and understand English

You may not qualify if:

• Carrying multiple fetuses
• Gestational diabetes mellitus at study entry
• Type 2 diabetes mellitus or blood glucose \>125 mg/dl at screening
• Self reported current substance abuse
• Current smoking
• Alchol consumption of more than 1 drink per day
• Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing
• Eating disorder in the past 2 years
• Depression or diagnosis of bipolar disorder
• Concurrent participation in any other research study that would impact participation in this investigation

Sponsors & Collaborators

• Tufts University: lead

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Tufts University Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan B Roberts, Ph.D.

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Energy Metabolism Laboratory

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

US (2)