Interventions to Reduce Excess Weight Gain in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dietary and Lifestyle Interventions in Obese Pregnant Women

NCT02095028

Obesity Weight Gain Lifestyle +1 more

COMPLETED NA

Promoting Healthy Weight Across the Pregnancy and Postpartum Period

NCT04253977

Obesity

UNKNOWN PHASE2

Lifestyle and Pregnancy: The Clinical Effect of Lifestyle Intervention During Pregnancy in Obese Women

NCT00530439

Maternal Obesity Gestational Weight Gain Obstetric Complications

COMPLETED NA

Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women

NCT01918423

Childhood Obesity

COMPLETED

Pregnancy Exercise Mode Effect on Childhood Obesity

NCT04805502

Pregnancy Overweight and Obesity

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Intervention to reduce excess weight gain during pregnancy

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Intervention to reduce excess weight gain during pregnancy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No