NCT02965729

Brief Summary

The purpose of the study was to examine the influence of step goals with pedometers to improve children's weight loss, physical activity, and psychosocial health during behavioral treatment. Children with overweight or obesity were assigned to receive the behavioral treatment alone, plus pedometers, or plus pedometers with step goals.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 7, 2019

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

November 14, 2016

Results QC Date

May 22, 2018

Last Update Submit

August 25, 2022

Conditions

Keywords

behavior goalsself-monitoringpedometerphysical activity

Outcome Measures

Primary Outcomes (1)

  • BMI Z-score Change

    Height was measured at sessions 1 and 10 using a stadiometer. Weight was measured at each session using a calibrated scale. BMI z-score was calculated from the Centers for Disease Control and Prevention macro program based on the sex, height, and age of the child. Change was calculated as difference between baseline and end of 10-week study.

    10 weeks

Secondary Outcomes (6)

  • BMI Change

    10 weeks

  • Body Weight Change

    10 weeks

  • Quality of Life Kidscreen-10 Index Change

    10 weeks

  • Physical Activity Enjoyment Change

    10 weeks

  • Subjective Health Change

    10 weeks

  • +1 more secondary outcomes

Study Arms (3)

No Pedometer

ACTIVE COMPARATOR

Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.

Behavioral: Family-based weight management

Pedometer Only

ACTIVE COMPARATOR

In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.

Behavioral: Family-based weight managementBehavioral: Pedometer

Pedometer Plus Step Goals

ACTIVE COMPARATOR

In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).

Behavioral: Family-based weight managementBehavioral: PedometerBehavioral: Individualized step goals

Interventions

The "Our Lifestyles, Our Lives" family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format.

No PedometerPedometer OnlyPedometer Plus Step Goals
PedometerBEHAVIORAL

In addition to participating in the family-based weight management intervention, participants were given a pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL) and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10.

Also known as: Activity monitor
Pedometer OnlyPedometer Plus Step Goals

In addition to participating in the family-based weight management intervention, participants were given a step goal to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).

Pedometer Plus Step Goals

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 8-17 years old
  • BMI ≥ 95th percentile or have a BMI ≥ 85th percentile with comorbidities (e.g. hypertension, heart disease, type 2 diabetes, insulin resistance, sleep apnea, orthopedic problems, or fatty liver disease)

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Staiano AE, Beyl RA, Hsia DS, Jarrell AR, Katzmarzyk PT, Mantzor S, Newton RL Jr, Tyson P. Step Tracking with Goals Increases Children's Weight Loss in Behavioral Intervention. Child Obes. 2017 Aug;13(4):283-290. doi: 10.1089/chi.2017.0047. Epub 2017 Apr 25.

MeSH Terms

Conditions

Pediatric ObesityWeight LossMotor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Results Point of Contact

Title
Dr. Amanda Staiano
Organization
Pennington Biomedical Research Center

Study Officials

  • Amanda E Staiano, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Research

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 17, 2016

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 29, 2022

Results First Posted

August 7, 2019

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share