'Food, Fun, Fresh, Family' Program for Healthy Eating and Growth for Elementary-age Children.

NCT ID: NCT06010784

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-06
• Study Completion Date: 2024-08-01

Brief Summary

The goal of this community-based randomized trial in elementary-aged children and a caregiver (parent/guardian) is to test the effect of providing families with produce and grocery store gift cards (family support) in conjunction with an after-school program for physical activity and healthy eating on improving children's overall diet, in comparison to the child only attending the after-school program without the family support.

Participating families will:

• receive weekly produce bags delivered to their home, recipes, and gift cards to a local grocery store (family support)
• the child will attend the after-school program during the school year

Researchers will compare the child's diet and eating scores with those in the after-school program alone.

Detailed Description

Children in grades 1 to 5 and enrolled in after-school program offered by the Boys & Girls Clubs of Austin Area (BGCAA) in selected schools, together with their caregiver (a parent/guardian), will be randomized into one of the two arms:

• Intervention group will receive, for 4 wks, 10 lbs of produce delivered weekly at home and one USD 20 gift card sent bi-weekly (total USD 40). Then, for 15 wks, the caregiver will receive every other week an electronic interactive health goals reminder survey to complete, for which they receive USD10 if completed. The goal sheets are optional activities.
• Control group will receive $120 as grocery store e-gift cards at the end of the study.

Regardless of the allocation arm, the child will attend the BGCAA's afterschool program as part of their family's association with the organization. The program runs daily, and the children are encouraged to attend at least 2x/wk. The "Coordinated Approach to Child Health" (CATCH) program will be delivered as part of the BGCAA program 2x/week.

Primary question: Does a 19-week after-school evidence-based program on nutrition education and physical activity for elementary-aged children improve overall child diet better when resources to encourage healthy eating are also provided to caregivers than when such resources are not provided?

Conditions

Diet, Healthy Growth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention: After-school program + family support

Group Type: EXPERIMENTAL

Family support

Intervention Type: BEHAVIORAL

• Family tip sheets sent via mobile text at the start of the program and then every 3 weeks, to a total of 6 mobile text messages
• Weeks 1-4 (4 weeks):

i. Welcome package mailed in the first week of the program ii. Weekly: one 10-lbs box of produce iii. Recipes accompanying each box (sample recipe card attached to submission) iv. Bi-Weekly: Grocery store gift cards (2x USD 20, to a total of USD 40)

• Weeks 5-19 (total of 10 weeks over the 19-week study timeline):

i. An optional online form ("goal sheet") is sent to the parent/caregiver every other week (total 5) with questions about trying new FV items to be submitted in the next 7 days. As an incentive, a USD 10 gift card is sent to those who complete it (a potential total of USD 50).

ii. Week 11: an extra USD 20 gift card in the week after a school holiday to re-engage participants due to the school-year break.

BGCAA's after-school program with CATCH curriculum

Intervention Type: BEHAVIORAL

1. The whole BGCAA's after-school program runs for 3h, Mon-Fri for the school year across all sites where the organization offers the program. All children enrolled are expected to attend a minimum of 2x/week.

2. In the BGCAA's after-school program, children participate in active recreational time (approx. 60 min, offered 1x/week at a minimum) which is a mixture of free play, structured physical activity games, and/or sports activities (including soccer, football, and basketball).

3. Uniquely to sites participating in the study, BGCAA's staff will deliver selected CATCH (Coordinated Approach to Child Health) curriculum components in blocks of 45-60 min, 2x/week, as part of the after-school program. The curriculum will focus on healthy eating education and physical activity designed for elementary school-aged children. More information on CATCH at https://catch.org/ (accessed 8/11/2023)

Control: After-school program only

Group Type: ACTIVE_COMPARATOR

BGCAA's after-school program with CATCH curriculum

Intervention Type: BEHAVIORAL

1. The whole BGCAA's after-school program runs for 3h, Mon-Fri for the school year across all sites where the organization offers the program. All children enrolled are expected to attend a minimum of 2x/week.

2. In the BGCAA's after-school program, children participate in active recreational time (approx. 60 min, offered 1x/week at a minimum) which is a mixture of free play, structured physical activity games, and/or sports activities (including soccer, football, and basketball).

3. Uniquely to sites participating in the study, BGCAA's staff will deliver selected CATCH (Coordinated Approach to Child Health) curriculum components in blocks of 45-60 min, 2x/week, as part of the after-school program. The curriculum will focus on healthy eating education and physical activity designed for elementary school-aged children. More information on CATCH at https://catch.org/ (accessed 8/11/2023)

Interventions

Family support

• Family tip sheets sent via mobile text at the start of the program and then every 3 weeks, to a total of 6 mobile text messages
• Weeks 1-4 (4 weeks):

i. Welcome package mailed in the first week of the program ii. Weekly: one 10-lbs box of produce iii. Recipes accompanying each box (sample recipe card attached to submission) iv. Bi-Weekly: Grocery store gift cards (2x USD 20, to a total of USD 40)

• Weeks 5-19 (total of 10 weeks over the 19-week study timeline):

i. An optional online form ("goal sheet") is sent to the parent/caregiver every other week (total 5) with questions about trying new FV items to be submitted in the next 7 days. As an incentive, a USD 10 gift card is sent to those who complete it (a potential total of USD 50).

ii. Week 11: an extra USD 20 gift card in the week after a school holiday to re-engage participants due to the school-year break.

Intervention Type: BEHAVIORAL

BGCAA's after-school program with CATCH curriculum

1. The whole BGCAA's after-school program runs for 3h, Mon-Fri for the school year across all sites where the organization offers the program. All children enrolled are expected to attend a minimum of 2x/week.

2. In the BGCAA's after-school program, children participate in active recreational time (approx. 60 min, offered 1x/week at a minimum) which is a mixture of free play, structured physical activity games, and/or sports activities (including soccer, football, and basketball).

3. Uniquely to sites participating in the study, BGCAA's staff will deliver selected CATCH (Coordinated Approach to Child Health) curriculum components in blocks of 45-60 min, 2x/week, as part of the after-school program. The curriculum will focus on healthy eating education and physical activity designed for elementary school-aged children. More information on CATCH at https://catch.org/ (accessed 8/11/2023)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Index guardian must be at least 18 years old
• Child must be enrolled in grade 1 to 5 (aged approx. 6-11 y-o) for the 2023-2024 school year
• Child must be enrolled in the BGCAA after-school program at the beginning of the 2023-24 fall semester at one of the 11 sites where BGCAA offers after-school program to elementary school-aged children
• Index parent must be able to speak English and/or Spanish

Exclusion Criteria

• Already having a sibling enrolled in the study
• Child having serious food allergies or dietary restrictions associated with produce products

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boys & Girls Clubs of the Austin Area

UNKNOWN

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Maninder Kahlon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maninder Kahlon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Boys & Girls Clubs of Austin

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00004545

Identifier Type: -

Identifier Source: org_study_id