NCT03805516

Brief Summary

This project examines the feasibility of a smartphone-based intervention to reduce obesity and breast cancer risk among Chinese American women in San Francisco. The proposed intervention is to use the mobile application and an activity tracker device to promote a healthier lifestyle and physical activity. Ultimately, the findings will advance the NIH mission of enhancing health promotion and disease prevention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

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

January 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

October 16, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

January 9, 2019

Last Update Submit

November 28, 2023

Conditions

Obesity, AbdominalCancer Prevention

Outcome Measures

Primary Outcomes (2)

  • waist circumference

    waist measured in centimeters by NIH waist circumference measurement protocol

    Change from baseline waist measurement at 3 months and 6 months

  • breast cancer knowledge and attitudes

    13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening

    Change from baseline breast cancer screening knowledge score at 3 months and 6 months

Secondary Outcomes (8)

  • body mass index

    change from baseline BMI at 3 months and 6 months

  • self-efficacy

    Change from baseline self-efficacy questionnaire score at 3 months and 6 months

  • food intake

    Change from baseline food frequency at 3 months and 6 months

  • physical activity

    Change from baseline daily physical activity at 3 months and 6 months

  • blood pressure

    Change from baseline blood pressure at 3 months and 6 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Number of uses of the tracking app

    at 6 months

  • Frequency of accessing the 12 educational modules

    at 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns. 2. 12 weekly SCOPP-CW educational modules delivered via WeChat. 3. 6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences

Behavioral: SCOPP-CW

Control

ACTIVE COMPARATOR

1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns. 2. 12 weekly non-tailored educational modules on general health topics delivered via WeChat.

Behavioral: Control

Interventions

SCOPP-CWBEHAVIORAL

The proposed intervention integrates the Social Cognitive Theory, use of everyday technology (WeChat), and an adaptation of an evidence-based program that is tailored to the behavior patterns, preferences, and cultures of premenopausal Chinese American women. The intervention includes three components: (1) daily tracking of physical activities, (2) 12 weekly educational modules on healthy lifestyle, physical activity, and breast cancer prevention, and (3) 6 bi-weekly tailored messages to include tips for lifestyle modification, stress management, and healthy weight maintenance based on the user's personal characteristics and behavior patterns.

Intervention
ControlBEHAVIORAL

This is the comparative/control group for the intervention. The control group receives daily tracking of physical activity and 12 weekly non-tailored educational information on general health topics.

Control

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be female
  • be at least 18 years old
  • have a waist circumference great than 80 cm
  • own a smartphone
  • be able to read Chinese and speak Mandarin
  • be premenopausal
  • have a child between the age of 1 and 18 years old.

You may not qualify if:

  • are pregnant
  • gave birth less than 12 months prior to enrollment date
  • have a history of breast cancer
  • have an acute or life-threatening disease (e.g., renal failure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco State University

San Francisco, California, 94132, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fang-yu Chou, PhD

    San Francisco State University

    PRINCIPAL INVESTIGATOR

  • Jyu-Lin Chen, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 15, 2019

Study Start

October 16, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)