Clinical trial NCT01203215: Examining Two Print-based Exercise Interventions for Women
Official title: Evaluating Self-Help Programs for Exercise Adoption and Maintenance in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Physical Activity Behavior
Keywords: exercise
physical activity
women
community
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
First posted: 2010-09-16
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical activity
timeFrame: 3 months
Secondary outcomes:
measure: physical activity
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References:
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):447-53. doi: 10.1016/j.ypmed.2006.06.011. Epub 2006 Aug 17.
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 2009 Sep 24.
citation: 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.