Nutrition Intervention and Play Group Exercise for Low-income Latinas

NCT00454948 | Completed DMC

• 1 other identifier: R01DK073377-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity among Mexican-American women has the potential to become a public health crisis. Hispanics are one of the fastest growing minority populations in the United States and the prevalence of obesity in Mexican American woman is increasing at an alarming rate. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, and lack of exercise are thought to be associated with women's excess weight gain. Accordingly, interventions are needed to improve the dietary intake and physical activity levels of Mexican-American families. We propose to conduct a randomized clinical trial in which women are randomly assigned to receive either family-based behavioral counseling (FBC) sessions and play group physical activity sessions or group based nutrition and exercise classes and health related activity worksheets to complete with their child. The FBC sessions, conducted by community health advisors, will use photographs of the family's food practices, taken by mothers, as visual aids in the counseling sessions. The control intervention will consist of group sessions using curricula designed to motivate women to exercise and to promote the Food Guide Pyramid recommendations using traditional Mexican-American foods. The primary outcome of the trial is mother's BMI. The secondary outcomes are dietary intake, moderate to vigorous physical activity and household food supplies. We hypothesize that within a one year time frame, women who are exposed to the FBC will have lower BMI's compared to women who receive the active placebo control intervention. The mechanisms through which we intend to change weight status are altering the type of foods purchased and cooking practices and promoting mothers to engage in physical activities with their children during their play. Measurements of secondary outcomes include three 24 hour dietary recalls, a household food inventory and activity monitoring using MTI actigraph monitors. In addition, mothers' reports of household food security level, and food purchase motives, will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up.

Conditions

Obesity

Keywords

Obesity prevention; Dietary intake; Physical activity; Mexican American; Family Characteristics

Outcome Measures

Primary Outcomes (1)

• BMI at one year after randomization

Secondary Outcomes (3)

• BMI percentile score of children one year after intervention

• Dietary intake of mothers and their child one year after intervention as measured by multiple 24 hour recalls

• Physical activity of mother and their child as measured by actigraph monitoring.

Study Arms (2)

Home based Nutrition and Physical Activity

EXPERIMENTAL

Home-based nutrition sessions and park play activity sessions

Behavioral: Home-based nutrition sessions and play group exercise

Group Nutrtion

ACTIVE COMPARATOR

Group based nutrition classes and activity booklets

Behavioral: Group-based nutrition sessions and mail-out activities

Interventions

Home-based nutrition sessions and play group exercise BEHAVIORAL

Home based Nutrition and Physical Activity

Group-based nutrition sessions and mail-out activities BEHAVIORAL

Group Nutrtion

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother is of Mexican descent
• Mother has a child between the ages of 3 and 4.9 years

You may not qualify if:

• Child is eligible for kindergarten in the upcoming 6 months
• Mother is pregnant
• Mother is less then 4 months post partum
• Family plans on moving outside of San Jose in the upcoming 6 months
• Family shares food supplies with more than one other household
• Mother has medical condition or takes medication that affects weight
• Child has medical condition or takes medication that affects weight or growth

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Unknown Facility

San Jose, California, United States

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Donna M Matheson, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2009
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

US (1)