Examining Two Print-based Exercise Interventions for Women

Physical Activity Behavior Clinical Trial

— WWP  

Official title:

Evaluating Self-Help Programs for Exercise Adoption and Maintenance in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203215
• Other study ID #: RWJF044224
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: November 4, 2011
• Start date: June 2002
• Est. completion date: December 2005

Study information

• Verified date: September 2010
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Activity Behavior

Intervention

Behavioral:
• 2 print based physical activity interventions
physical activity promotion

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	The Miriam Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dutton GR, Napolitano MA, Whiteley JA, Marcus BH. Is physical activity a gateway behavior for diet? Findings from a physical activity trial. Prev Med. 2008 Mar;46(3):216-21. doi: 10.1016/j.ypmed.2007.12.012. Epub 2008 Jan 29. — View Citation

McAndrew LM, Napolitano MA, Albrecht A, Farrell NC, Marcus BH, Whiteley JA. When, why and for whom there is a relationship between physical activity and menopause symptoms. Maturitas. 2009 Oct 20;64(2):119-25. doi: 10.1016/j.maturitas.2009.08.009. Epub 20 — View Citation

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity		3 months	No
Secondary	physical activity		12 months	No