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Interventions to Reduce Excess Weight Gain in Pregnancy

Primary Purpose

Overweight and Obesity, Pregnancy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intervention to reduce excess weight gain during pregnancy

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring weight, pregnancy, behavioral intervention, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Tufts Medical Center
Tufts University Human Nutrition Research Center on Aging

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Fiber Cereal

Control Group

Resistant Starch

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Infant Outcomes

Body composition (i.e. length, head circumference, skinfold thickness, waist circumference) changes through the first year. Characteristics at birth including Apgar score, gestational age. Dietary intake and food preferences at 1 year.

Maternal and Perinatal Outcomes

Rates of cesarean delivery, gestational hypertension/preeclampsia, preterm birth, birth complications. Fasting blood glucose and insulin concentrations throughout pregnancy. Body composition and energy requirements at baseline and 24-28 weeks of pregnancy. Total energy expenditure at 24-28 weeks of pregnancy. Rate of breastfeeding and breastfeeding practices at 1, 3, 6, and 12 months post-partum.

Full Information

NCT ID

NCT01643356

First Posted

July 16, 2012

Last Updated

May 9, 2016

Sponsor

Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT01643356

Brief Title

Interventions to Reduce Excess Weight Gain in Pregnancy

Official Title

Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Pregnancy

Keywords

weight, pregnancy, behavioral intervention, obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fiber Cereal

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Arm Title

Resistant Starch

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Intervention to reduce excess weight gain during pregnancy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maternal and Infant Body Weight Change

Description

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.

Time Frame

From first trimester through 1 year post-partum

Secondary Outcome Measure Information:

Title

Infant Outcomes

Description

Time Frame

From birth through first year

Title

Maternal and Perinatal Outcomes

Description

Time Frame

First trimester through 1 year post-partum

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan B Roberts, Ph.D.

Organizational Affiliation

Tufts University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Tufts University Human Nutrition Research Center on Aging

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

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Interventions to Reduce Excess Weight Gain in Pregnancy

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