Interventions to Reduce Excess Weight Gain in Pregnancy

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT01643356

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Pregnancy	Behavioral: Intervention to reduce excess weight gain during pregnancy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fiber Cereal 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 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.
No Intervention: Control Group Women assigned to this arm of the study will receive routine clinical care and no additional interventions.
Active Comparator: Resistant Starch 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 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.

Arm

Intervention/Treatment

Active Comparator: Fiber Cereal

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

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.

No Intervention: Control Group

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

Active Comparator: Resistant Starch

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

Outcome Measures

Primary Outcome Measures

Maternal and Infant Body Weight Change [From first trimester through 1 year post-partum]
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 [From birth through first year]
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 [First trimester through 1 year post-partum]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111
2	Tufts University Human Nutrition Research Center on Aging	Boston	Massachusetts	United States	02111