NCT01819987

Brief Summary

About 17% of Chinese American preschool children are obese, compared to 12.4%of all children from age three to five years residing in the US; the prevalence of obesity is expected to increase in the future. Therefore, the proposed study will adapt a home-based and technology-centered childhood obesity prevention program for low-income Chinese American mothers of children three to five years old. The aims of the study are to assess the feasibility of the intervention and estimate the effect sizes on children's and mothers' outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 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
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

March 18, 2013

Last Update Submit

May 9, 2017

Conditions

Keywords

Overweightmotherchildhood obesity preventionChinese American

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline body mass index at 5 months

    Participants will have their weight and height measured and body mass index will be calculated. Change of BMI from baseline will be assessed at 5 months post baseline

    Baseline and at 5 months

Secondary Outcomes (8)

  • Change from baseline physical activity at 2 months

    Baseline and 2 months

  • Change from Baseline Sedentary activity at 2 months

    baseline and 2 months

  • Change from Baseline Parental Feeding Practice at 2 months

    baseline and 2 months

  • Change from Baseline Self-efficacy regarding diet and physical activity at 2 months

    baseline and 2 months

  • Change from baseline physical activity level at 5 months

    Baseline and 5 months

  • +3 more secondary outcomes

Study Arms (2)

Mailing information

ACTIVE COMPARATOR

Participants in the mailing information group will receive general health promotion topics relevant to preschool-age children (such as immunization, injury prevention and school readiness) via mailing materials that are bilingual weekly for eight weeks. These materials will be obtained from CDC and AAP.

Behavioral: Mailing information

Tablet computer

EXPERIMENTAL

Participants in the intervention group will receive eight weekly online sessions and interactive activities delivered through tablet computers. Intervention participants will receive instructions for accessing the program via the tablet at an in-person session. Automated weekly emails will be sent to participating mothers for the intervention duration to encourage study engagement.

Behavioral: Tablet computer

Interventions

Tablet computerBEHAVIORAL

Participants in the intervention group will receive eight weekly online sessions and interactive activities delivered through tablet computers. Intervention participants will receive instructions for accessing the program via the tablet at an in-person session. Automated weekly emails will be sent to participating mothers for the intervention duration to encourage study engagement.

Tablet computer

Participants in the control group will receive general health promotion topics relevant to preschool-age children (such as immunization, injury prevention and school readiness) via mailing materials that are bilingual weekly for eight weeks. These materials will be obtained from CDC and AAP.

Mailing information

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Children:
  • must be between ages three and five
  • have a mother who identifies her child as Chinese;
  • be healthy-defined as free of chronic or acute illness.
  • Mothers:
  • must identify themselves as Chinese
  • the primary provider of the child,
  • be able to speak and read Chinese or English;
  • with a BMI \>= 23.0;
  • meet low-income requirements in the Bay Area.

You may not qualify if:

  • Have acute or chronic conditions that prevent performing daily activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 64143, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jyu-Lin Chen, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigator and outcome assessor were blinded to the group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized, controlled study was used. The intervention group received tablet based intervention and the control group received printed health information relevant to preschool-aged children in Chinese over the eight weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 28, 2013

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations