NCT02365324

Brief Summary

The proposed integrated project will evaluate the effects of an evidence-based extension education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of delivery on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns \[i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010\] and SCT variables. Briefly, the 12-week program will target early adolescent children, ages 11-14 years, test a peer-education approach to behavioral change and will be delivered as an after-school program in local middle schools in support of childhood obesity prevention. Data will be collected at baseline (preintervention), after the 12-week program (post-intervention) and 6 months after completion of the program (maintenance).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 4, 2019

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

February 2, 2015

Last Update Submit

September 3, 2019

Conditions

Keywords

culinary skillsmenu planninggrocery shoppingchildrenhealthy eatingphysical activity

Outcome Measures

Primary Outcomes (9)

  • Change in Demographic data

    Children will complete a standardized questionnaire to provide age, gender, race/ethnicity, grade level and home address. Information about health (any acute or chronic illnesses) and health care services utilization (frequency of doctor's visits, use of specialists, medication use or need) will be provided by parents.

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Goal setting tool

    Children and parents will complete the Goal Setting for Family Fitness tool. Children and adults, respectively, will complete the Child or Adult versions of the Pre-Survey (baseline), Post-Survey (post-intervention) and Follow-Up Survey (6-months post-intervention).

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in 24-hour dietary intake recall

    24-hour dietary intake recall completed by the multiple-pass method in an interview format.

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in 3-day dietary intake record

    3-day dietary intake record (2 weekdays+1 weekend day).

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in 24-hour physical activity recall

    Average energy expenditure of children (kcals/day) will be estimated from 1, 24-hour physical activity recall completed in an interview format.

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in 3-day physical activity record

    3-day physical activity record (2 weekdays+1 weekend day).

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in Anthropometric measurements

    In a private room with the child's parent present, a graduate research assistant (GRA) will measure the child's BW (kg) on a calibrated scale (Seca 700, Hanover, MD) to the nearest 0.1 kg and body height (cm) to the nearest 0.1 cm with a calibrated, standing stadiometer (Seca 700).

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in Social Cognitive Theory (SCT) variables

    Social/family support, self-efficacy, self-regulation and outcome expectations for balancing calories to manage BW, reducing certain foods and food components, increasing selected foods and nutrients and building healthy eating patterns will be assessed by questionnaires.

    Evaluation at three time points: 0 months, 2 months and 8 months

  • Changes in blood pressure (BP) measurements

    Seated systolic and diastolic BP (mmHg) will be measured by a trained GRA, using a sphygmomanometer (Baumanometer® Desk Model, Copiague, NY). Two BP measurements will be recorded with a 3-minute rest period between readings; values will be averaged.

    Evaluation at three time points: 0 months, 2 months and 8 months

Secondary Outcomes (3)

  • Process measure questionnaire

    One questionnaire for each of the 12 sessions of the program (An average of six to twelve weeks)

  • Education measures

    Once, at the end of the 12 week intervention

  • Extension measures

    Once, at the end of the 12 week intervention

Study Arms (2)

Peer-education Family Fitness Program

EXPERIMENTAL

Peer educators (children in grade 8) recruited from the schools participating in the study will be trained and will then be implementing the 12 week Peer-education Family Fitness Program (PE-FFP) intervention to children in 6th and 7th grade.

Behavioral: Peer-Education Family Fitness Program (PE-FFP)

Family Fitness Program (FFP)

OTHER

Adult educators recruited from the University of Illinois Extension or the community will be trained and will then be implementing the 12 week Family Fitness Program (FFP) intervention to children in 6th and 7th grade.

Behavioral: Family Fitness Program (FFP)

Interventions

The proposed integrated project will be implemented by peers and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (with and without a peer-education mode of delivery) on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns \[i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010\] and SCT variables.

Also known as: PAWS Club: Peer-education About Weight Steadiness
Peer-education Family Fitness Program

The proposed integrated project will be implemented by adults and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (with and without a peer-education mode of delivery) on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns \[i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010\] and SCT variables.

Also known as: PAWS Club: Peer-education About Weight Steadiness
Family Fitness Program (FFP)

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in grade 6 or grade 7, 11-14 years old and their parents, enrolled in the schools participating in the study

You may not qualify if:

  • Children younger than 11 years or older than 14 years, not enrolled in the schools participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Franklin Middle School

Champaign, Illinois, 61820, United States

Location

Jefferson Middle School

Champaign, Illinois, 61822, United States

Location

Mahomet Seymour-Junior High School

Mahomet, Illinois, 61853, United States

Location

Urbana Middle School

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Muzaffar H, Nikolaus CJ, Ogolsky BG, Lane A, Liguori C, Nickols-Richardson SM. Promoting Cooking, Nutrition, and Physical Activity in Afterschool Settings. Am J Health Behav. 2019 Nov 1;43(6):1050-1063. doi: 10.5993/AJHB.43.6.4.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Sharon Nickols-Richardson, PhD, RD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 18, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 4, 2019

Record last verified: 2016-11

Locations