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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03047590
Other study ID # D0991
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2017
Est. completion date March 29, 2018

Study information

Verified date July 2018
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate adherence to four types of walking programs. Participants will be randomized to walking programs that included either (1) affect-based exercise intensity, (2) self-selected (or "choice-based") exercise intensity, (3) heart-rate based exercise intensity, or (4) heart-rate guided exercise intensity with the emphasis on affective benefits.


Description:

The purpose of this study is to determine if an "affect-based" or "choice-based" exercise prescription is more effective for behavior change than a traditional, "moderate-intensity" exercise prescription. Prior research suggests that "choice-based" or "self-selected" exercise intensity is more pleasant and adhered to than "moderate-intensity exercise" (Williams et al., 2014). Similarly, affect-based exercise prescriptions (i.e., an exercise prescription where intensity is regulated based on the pleasure-displeasure one feels while exercising) appear to have merit (Baldwin, Kangas, Denman, Smits, Yamada, & Otto, 2016).

However, choice-based and affect-based exercise prescriptions have not been compared to each other. Further, it is unknown if it is the intensity regulation that matters (e.g., "choose an intensity that feels good" or the focus on affect (e.g., "focus on feeling good). Third, prior research has not objectively measured physical activity behavior.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date March 29, 2018
Est. primary completion date March 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be fluent in English

- Must be able to walk

- Exercise less than 90 minutes per week at a moderate-intensity

- Must be able to attend laboratory visits

- Must have mobile internet accent and a personal smartphone (iPhone iOS 9+ or Android OS 4.3+)

- Can safely exercise at an intensity that is at least "moderate"

Exclusion Criteria:

- People who are recommended to have medical clearance prior to exercising, according to the American College of Sports Medicine's preparticipation screening criteria, will be excluded

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Choice-based Exercise Intensity
Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
Positive Affect Focus
Participants are instructed to focus on feeling good while exercising.
Heart rate-based Exercise Intensity
Participants are instructed to regulate their exercise intensity based on their heart rate.

Locations

Country Name City State
United States Duke University IBRC Lab Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Baldwin AS, Kangas JL, Denman DC, Smits JA, Yamada T, Otto MW. Cardiorespiratory fitness moderates the effect of an affect-guided physical activity prescription: a pilot randomized controlled trial. Cogn Behav Ther. 2016 Nov;45(6):445-57. doi: 10.1080/16506073.2016.1194454. Epub 2016 Jun 16. — View Citation

Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in objectively measured exercise behavior Minutes per week of objectively measured exercise behavior. This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
Secondary Change in self-reported exercise behavior Minutes per week of self-reported exercise behavior that is reported using exercise log. This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)
Secondary Change in affective attitudes Affective attitudes toward exercise Measured during baseline assessment period and at the end of the intervention
Secondary Self-reported intrinsic motivation (questionnaires) Intrinsic motivation for exercise program Two weeks into study intervention
Secondary Enjoyment Enjoyment of exercise program. Measured at the end of the intervention period (4 weeks)
Secondary Change in weight Body weight Measured at the beginning and end of the study (6 weeks).
Secondary Change in resting heart rate Resting heart rate Measured at the beginning and end of the study (6 weeks).
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