Physical and Social Environmental Influence on Children's Exercise: Preparation (Pre-PLACE)

NCT03087123 | Completed DMC

• 1 other identifier: PBRC 2016-068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Community based interventions are more acceptable to community members when all participants receive the intervention. A 'stepped-wedge' or 'multiple-baseline' design allows for all participants to receive the intervention by randomizing participants into conditions defined by the length of the baseline period. The primary aim of this pilot study is to gather data that will allow the researchers to estimate parameters, such as the appropriate length of the baseline period that will allow them to power a larger study. A second key aim is to determine if a smartphone intervention that is delivered to parents can increase physical activity in their 6-10 year old inactive children.

Conditions

Physical Activity

Keywords

single-case design; children; health equity; mobile health

Outcome Measures

Primary Outcomes (1)

• Physical activity

  Fitbit®: The child will wear a wireless activity monitor (Fitbit®) for the entire study. The Charge 2 wrist-worn Fitbit will be utilized.

  Baseline.

Secondary Outcomes (6)

• Height

  Baseline, Week 4, 8, and 12.

• Weight

  Baseline, Week 4, 8, and 12.

• Body composition

  Baseline, Week 4, 8, and 12.

• Home and neighborhood environment questionnaire

  Baseline, Week 4, 8, and 12.

• Sibling Relationship Inventory (SRI).

  Baseline, Week 4, 8, and 12.

Study Arms (3)

2-Week Baseline

ACTIVE COMPARATOR

Families will be randomized to a 2-week baseline period before being administered the P-Mobile app based intervention. All families will receive the same P-Mobile intervention following the baseline period. The intervention will consist of 10 lessons delivered over 12 weeks designed to increase physical activity in children. The lessons will be delivered weekly and are the same ones utilized in the P-Mobile pilot study. The parents will also receive notifications designed to prompt physical activity, motivate, and remind parents of lesson content.

Behavioral: P-Mobile App

4-Week Baseline

ACTIVE COMPARATOR

Families will be randomized to a 4-week baseline period before being administered the P-Mobile app based intervention. All families will receive the same P-Mobile intervention following the baseline period. The intervention will consist of 10 lessons delivered over 12 weeks designed to increase physical activity in children. The lessons will be delivered weekly and are the same ones utilized in the P-Mobile pilot study. The parents will also receive notifications designed to prompt physical activity, motivate, and remind parents of lesson content.

Behavioral: P-Mobile App

6-Week Baseline

ACTIVE COMPARATOR

Families will be randomized to a 6-week baseline period before being administered the P-Mobile app based intervention. All families will receive the same P-Mobile intervention following the baseline period. The intervention will consist of 10 lessons delivered over 12 weeks designed to increase physical activity in children. The lessons will be delivered weekly and are the same ones utilized in the P-Mobile pilot study. The parents will also receive notifications designed to prompt physical activity, motivate, and remind parents of lesson content.

Behavioral: P-Mobile App

Interventions

P-Mobile App BEHAVIORAL

The behavioral strategies are based on Social Cognitive Theory. The following topics will be covered: self-monitoring, goal setting, stimulus control, making time for exercise, exercising in- and outdoors, problem-solving, reinforcing PA, reducing sedentary behaviors, relapse prevention, parental modeling, lifestyle exercise, self-efficacy, self-management, parental PA modeling, parental co-participation, and establishing PA rules. Parents will be provided with adapted step goals (based on principles of shaping). Text messages will be designed to prompt PA, remind parents of concepts from the lessons, and motivate behavioral change.

2-Week Baseline; 4-Week Baseline; 6-Week Baseline

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must:
• Be 6-10 years of age
• Have at least one participating parent.
• Be Physically capable of exercise
• Have an average steps/day less than the 50th percentile for age and gender (e.g., \<8,900 steps/day for 10-year old girls and \<10,200 steps/day for 10-year old boys).
• The parent must:
• Have a smartphone
• Be willing to download and use the P-Mobile app
• Demonstrate the ability to send text messages
• Have no plans to move during the study period (up to 4 months)
• Families must:
• Reside in targeted geographic area

You may not qualify if:

• Significant cardiovascular disease or disorders via self-report
• Other significant medical problems that would prevent them from engaging in regular physical activity.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Stephanie Broyles, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

• Robert L. Newton, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In accordance with a single case design approach, where each subject acts as his/her own control, families will be randomized to a 2, 4, or 6-week baseline period before being administered the P-Mobile app based intervention. All families will receive the same P-Mobile intervention following the baseline period.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 22, 2017
• Study Start: April 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)