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Completed

NCT Number: NCT02965729

Our Lifestyles Our Lives

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.

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Key information

Conditions

Pediatric Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A total of 105 overweight and obese children ages 8 to 17 years participated in a 10-week family-based weight management intervention focusing on physical activity, nutrition, and behavioral modification. A quasi-experimental design was used to group cohorts into three conditions: two cohorts had no pedometer (n=24); two cohorts had pedometer only (n=25); and four cohorts had pedometer with step goals (i.e. 500 steps/day weekly increase above baseline; n=56). Height and weight were measured at baseline and week 10 and used to calculate body mass index (BMI). Analysis of covariance was performed to examine difference by condition for change in weight, BMI, and BMI z-score, controlling for age and baseline value. Differences in steps/day and psychosocial health were compared between the two pedometer conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • None.

Treatment and study plan

Family-based weight management

Behavioral

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.

pedometer

Behavioral

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.

Other names: Activity monitor

Individualized step goals

Behavioral

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).

Primary outcomes

  1. BMI Z-score Change

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. BMI Change

    Time frame: 10 weeks

    BMI was calculated as weight in kg divided by height in meters squared. Change was calculated as difference between baseline and end of 10-week study.

  2. Body Weight Change

    Time frame: 10 weeks

    Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.

  3. Quality of Life Kidscreen-10 Index Change

    Time frame: 10 weeks

    Health-related quality of life was measured using the Kidscreen-10 Index. Change was calculated as difference between baseline and end of 10-week study. the scale ranged from 0 to 15, with higher values indicating a better outcome.

  4. Physical Activity Enjoyment Change

    Time frame: 10 weeks

    Physical activity enjoyment was measured using the Physical Activity Enjoyment Scale (PACES). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 32, with higher values indicating a better outcome.

  5. Subjective Health Change

    Time frame: 10 weeks

    Subjective health was measured using a 1-item Likert scale ("In general, how would you say your health is?"). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 4, with higher values indicating a better outcome.

  6. Physical Activity Change

    Time frame: 10 weeks

    Physical activity was measured in the pedometer only and pedometer plus goals groups using an Omron pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL). Change was calculated as difference between baseline and end of 10-week study.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • American Council on Exercise
  • Our Lady of the Lake Hospital

Registry information

Official study title

Our Lifestyles, Our Lives: Obesity Treatment and Physical Activity Promotion for Underserved Children and Adolescents

Acronym: OLOL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2016
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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