NCT02338765

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

January 7, 2015

Last Update Submit

June 8, 2016

Conditions

Physical ActivityObesity

Outcome Measures

Primary Outcomes (1)

  • Daily steps

    weekly during study period, up to 12 weeks

Secondary Outcomes (3)

  • 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)

    Changes in HC over the 12-week study period

Study Arms (2)

Buddy

EXPERIMENTAL

Physical activity plus having a buddy

Behavioral: mHealth Physical ActivityBehavioral: Buddy-partnered exercise

Control

ACTIVE COMPARATOR

Physical activity only

Behavioral: mHealth Physical Activity

Interventions

mHealth Physical ActivityBEHAVIORAL
BuddyControl
Buddy-partnered exerciseBEHAVIORAL
Buddy

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Adjunct Professor

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 10, 2016

Record last verified: 2016-06

Locations

US(1)