NCT01110213

Brief Summary

The primary aim of this feasibility study is to determine if a theory-based lifestyle intervention consisting of telephone counseling is associated with improvements in physical activity and dietary intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2010

Completed
Last Updated

April 26, 2010

Status Verified

April 1, 2010

Enrollment Period

7 months

First QC Date

April 21, 2010

Last Update Submit

April 22, 2010

Conditions

Keywords

Agingphysical activitydietgoal setting

Outcome Measures

Primary Outcomes (1)

  • Leisure Time Physical Activity

    Physical Activity was measured using an adaptation of the Godin Leisure-Time Exercise Questionnaire. Participants reported how many times during an average week they participated in mild (i.e., takes minimal effort), moderate (i.e., increases your heart and breathing rate a little), and strenuous activity (i.e., caused one's heart to beat rapidly) for at least 30 minutes at a time.

    8-weeks

Secondary Outcomes (1)

  • Goal specificity and difficulty

    8-weeks

Study Arms (2)

Physical activity

EXPERIMENTAL

Participants received individual tailored telephone counseling and group-tailored newsletters encouraging leisure time physical activity. Content was based on goal setting theory and decisional balance.

Behavioral: Physical activity

Fruit and vegetable

EXPERIMENTAL

Participants received individual tailored telephone counseling and group-tailored newsletters encouraging fruit and vegetable intake. Content was based on goal setting theory and decisional balance.

Behavioral: Fruit and vegetable

Interventions

Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for physical activity.

Physical activity

Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for fruit and vegetable consumption.

Fruit and vegetable

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be 55 years or older,
  • posses a telephone,
  • able to give informed consent, and
  • commit to a 10 week study.

You may not qualify if:

  • currently enrolled in a study promoting physical activity or dietary intake,
  • currently exceeding current recommendations for physical activity or F\&V intake at baseline, and
  • medical conditions contraindicating physical activity or fruit and vegetable consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Research Center of Hawaii / University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseFruitVegetables

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Raheem J Paxton, PhD

    University of Hawaii Cancer Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2010

First Posted

April 26, 2010

Study Start

August 1, 2006

Primary Completion

March 1, 2007

Study Completion

August 1, 2007

Last Updated

April 26, 2010

Record last verified: 2010-04

Locations