Starting Early Obesity Prevention Program

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

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2023-08-01

Brief Summary

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

The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.

The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices

Related Clinical Trials

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

Health e-Baby: Trial to Reduce Obesity Risk Factors During the First 1,000 Days

NCT05225649

Obesity, Infant

COMPLETED NA

Preschool Based Obesity Prevention Effectiveness Trial

NCT00241878

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED NA

A Nutrition and Parenting Program for Fathers and Their Pre-school Age Children

NCT03071419

Pediatric Obesity

COMPLETED NA

Implementing Prevention Plus for Childhood Overweight and Obesity in Food Secure and Insecure Families

NCT02684214

Obesity Childhood Obesity

COMPLETED NA

The Healthy Lifestyles Passport Program: a Nutrition Education Program to Prevent Childhood Obesity

NCT01649115

Childhood Obesity

UNKNOWN NA

Detailed Description

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

Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet.

Our secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts. The new components of the expanded Starting Early Program will be feasible: Families will participate in the preschool intervention, and pregnant women will enroll in the prenatal intervention.

Conditions

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

Childhood Obesity

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

SINGLE

Outcome Assessors

Study Groups

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

Family groups

Intervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic.

Group Type EXPERIMENTAL

Family groups

Intervention Type BEHAVIORAL

The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting.

Standard care

Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Family groups

The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Latina mother \> 18 years with singleton uncomplicated pregnancy
* Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
* Mother to be primary caregiver of child
* Mother speaks fluent English or Spanish

Exclusion Criteria

* Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
* Family does not have a phone
* Infants with severe medical problems that may affect feeding

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes