NCT03047590

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

February 2, 2017

Last Update Submit

July 6, 2018

Conditions

Keywords

exercise behaviorexercise prescriptionaffect-based exerciseaffect-guided exerciseself-paced exerciseself-selected exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in self-reported exercise behavior

    This will be measured throughout the baseline assessment period (2 weeks) and intervention period (4 weeks)

  • Change in affective attitudes

    Measured during baseline assessment period and at the end of the intervention

  • Self-reported intrinsic motivation (questionnaires)

    Two weeks into study intervention

  • Enjoyment

    Measured at the end of the intervention period (4 weeks)

  • Change in weight

    Measured at the beginning and end of the study (6 weeks).

  • +1 more secondary outcomes

Study Arms (4)

Choice-No Affect

EXPERIMENTAL

These participants self-select (i.e., choose) their exercise intensity with the goal of walking 30-60 minutes on most days of the week. For safety reasons, they are instructed not to exceed 59% of their heart rate reserve. This is choice-based exercise intensity with no focus on positive affect.

Behavioral: Choice-based Exercise Intensity

Choice-Affect

EXPERIMENTAL

These participants self-select their exercise intensity with the goal of walking 30-60 minutes on most days of the week. They're instructed to choose the intensity that makes them feel the best. For safety reasons, they are instructed not to exceed 59% of their heart rate reserve. This is choice-based exercise intensity with a focus on positive affect.

Behavioral: Choice-based Exercise IntensityBehavioral: Positive Affect Focus

No Choice-Affect

EXPERIMENTAL

These participants regulate their exercise intensity using their heart rate, with the goal of walking 30-60 minutes on most days of the week. The intensity is "moderate" according to the American College of Sports Medicine (40-59% of their heart rate reserve). Meanwhile, these participants are instructed to focus on the "good feelings" that come with exercise. this is heart rate-based exercise intensity with a focus on positive affect.

Behavioral: Positive Affect FocusBehavioral: Heart rate-based Exercise Intensity

No Choice-No Affect

ACTIVE COMPARATOR

These participants regulate their exercise intensity using their heart rate, with the goal of walking 30-60 minutes on most days of the week. The intensity is "moderate" according to the American College of Sports Medicine (40-59% of their heart rate reserve). This is heart rate-based exercise intensity with no focus on positive affect.

Behavioral: Heart rate-based Exercise Intensity

Interventions

Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.

Choice-AffectChoice-No Affect

Participants are instructed to focus on feeling good while exercising.

Choice-AffectNo Choice-Affect

Participants are instructed to regulate their exercise intensity based on their heart rate.

No Choice-AffectNo Choice-No Affect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University IBRC Lab

Durham, North Carolina, 27701, United States

Location

Related 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.

    PMID: 27310568BACKGROUND
  • 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.

    PMID: 25223963BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Associate

Study Record Dates

First Submitted

February 2, 2017

First Posted

February 9, 2017

Study Start

February 21, 2017

Primary Completion

March 29, 2018

Study Completion

March 29, 2018

Last Updated

July 9, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

The investigators retain ownership of all study data, but are willing to share anonymized data for transparency purposes at the conclusion of the study. Data may be requested by contacting the Principal Investigator.

Locations