A FAMILY Program for Childhood Overweight and Obesity

NCT ID: NCT03773250

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-07-31

Brief Summary

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Childhood overweight and obesity is a health problem with lifelong implications related to diabetes, hypertension, cardiovascular disease, psychological disorders as well as other chronic conditions.

Detailed Description

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In Taiwan, the nationwide prevalence of overweight and obesity among school-age children aged 7 to 11 years has also increased over the past years. Sleep and weight are intricately related. School-age children requires at least 10 hours of sleep per night but children in Asian countries are on average obtaining shorter sleep than children in Caucasian countries.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Behavioral Intervention

Children and families in the intervention group will received the FAMILY program developed according to evidence-based guidelines.The intervention content regarding healthy sleep will emphasize the importance of having a consistent sleep schedule, establishing a regular bedtime routine, and creating an environment only for sleeping. The physical activity content will emphasize at least 60 minutes/day of moderate-to-vigorous intensity physical activity, reduction of sedentary behavior, and screen time limited to 2 hours/day. The nutrition content will emphasis the replacement of sugar-sweetened beverages, increased fruit and vegetable as well as water intake, consumption of regular meals, and reduction of discretionary food groups.

Group Type EXPERIMENTAL

Behavioral intervention

Intervention Type BEHAVIORAL

The intervention has an intensive phase and a maintenance phase.

Control

An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education.

Group Type OTHER

Behavioral intervention

Intervention Type BEHAVIORAL

The intervention has an intensive phase and a maintenance phase.

Interventions

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Behavioral intervention

The intervention has an intensive phase and a maintenance phase.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children with overweight and obesity

Exclusion Criteria

* Children with any other chronic or acute medical conditions
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao-Yu Tsai, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201603121RIND

Identifier Type: -

Identifier Source: org_study_id

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