MoTHER Buddy Program | NCT02338765

Studies
MoTHER Buddy Program

NCT02338765

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Jun 10, 2016Estimated

Enrollment

54Actual

Phase

Not Applicable

Conditions

Physical Activity
Obesity

Interventions

mHealth Physical Activity
Buddy-partnered exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jan 7, 2015

First Submission Date that Met QC Criteria

Jan 9, 2015

First Posted Date

Jan 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2016

Last Update Posted Date

Jun 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

JiWon Choi, Assistant Adjunct Professor, University of California, San FranciscoPrincipal Investigator

Lead Sponsor

University of California, San FranciscoOTHER

Collaborators

Name	Class
American Heart Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buddy	Experimental	Physical activity plus having a buddy	Behavioral: mHealth Physical Activity Behavioral: Buddy-partnered exercise
Control	Active Comparator	Physical activity only	Behavioral: mHealth Physical Activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mHealth Physical Activity	Behavioral		Buddy Control
Buddy-partnered exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily steps		weekly during study period, up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Weight		Changes in weight over the 12-week study period
Waist Circumference (WC)		Changes in WC over the 12-week study period
Hip Circumference (HC)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physically inactive,
having at least one child aged less than 5 years,
having at least one family member or friend who can support physical activity engagement and reside in the same community,
having access to computer and phone, and
overweight/obese (Body Mass Index: 23 kg/m2 or more)

Exclusion Criteria:

Having known medical conditions that prevent regular physical activity and
current participation in other lifestyle modification programs

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94118	United States

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D009765	Obesity

Ancestor Terms

ID	Term
D001519	Behavior
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided