Examining Two Print-based Exercise Interventions for Women | NCT01203215

Studies
Examining Two Print-based Exercise Interventions for Women

NCT01203215

Sponsor

Temple University

Status

Completed

Last Update Posted

Nov 7, 2011Estimated

Enrollment

280Actual

Phase

Phase 2

Conditions

Physical Activity Behavior

Interventions

2 print based physical activity interventions

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

Sep 2010

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

Jun 2002

Primary Completion Date

Jun 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 14, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 16, 2010Estimated

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

Nov 4, 2011

Last Update Posted Date

Nov 7, 2011Estimated

Name	Class
The Miriam Hospital	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

Print-based interventions, specifically interventions that are theoretically-based have been shown to be effective for individuals. These types of interventions are of particular importance for those individuals who, due to transportation, work, family, social, or financial demands have difficulty participating in face-to-face programs. Therefore, we decided to test 2 such print based programs for women.

Detailed Description

We conducted a randomized controlled trial in which participants were randomly assigned to one of three groups: (1) Choose to Move (CTM), a gender-targeted intervention (2) Jumpstart, a motivationally-tailored print-based intervention, or (3) Wellness contact control group. Objective and self-report measures of physical activity and psychosocial mediators of change were assessed at 3 months to evaluate the efficacy of the programs and maintenance of these programs will be conducted by examining a 9 month follow-up phase. This design allows a direct comparison between two print-based physical activity self-help programs. The use of non face-to-face interventions is critical to reach the large numbers of women in United States who are not physically active. Tailored print materials (i.e., Jumpstart) will enable participants to have information that is matched to their level of motivation, and thus might be expected to be more efficacious than a standard self-help intervention.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
JumpStart	Experimental	Behavioral: 2 print based physical activity interventions
Choose to Move	Experimental	Behavioral: 2 print based physical activity interventions
Wellness	Active Comparator	Behavioral: 2 print based physical activity interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2 print based physical activity interventions	Behavioral	physical activity promotion	Choose to Move JumpStart Wellness

Measure	Description	Time Frame
Physical activity		3 months

Measure	Description	Time Frame
physical activity		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy women
sedentary

Exclusion Criteria:

participating in > 90 minutes of purposeful physical activity (e.g., walking, cycling).
medical problems that could potentially impede or exacerbated by physical activity
history of coronary heart disease
myocardial infraction
symptoms of angina
stroke
diabetes
osteoporosis
osteoarthritis
severe orthopedic problems.
a planned move from the area within the next year
current or planned pregnancy
hospitalization for a psychiatric disorder within the last 3 years
current suicidal or psychotic episodes
currently using certain prescription medication such as beta blockers for hypertension

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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
The Miriam Hospital		Providence	Rhode Island	02903	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16919322	Result	Napolitano MA, Whiteley JA, Papandonatos G, Dutton G, Farrell NC, Albrecht A, Bock B, Bazzarre T, Sciamanna C, Dunn AL, Marcus BH. Outcomes from the women's wellness project: a community-focused physical activity trial for women. Prev Med. 2006 Dec;43(6):447-53. doi: 10.1016/j.ypmed.2006.06.011. Epub 2006 Aug 17.
19781877	Result