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Good Intentions Study

Primary Purpose

Obesity, Overweight

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise-only
Control
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Body mass index from 18-45 kg/m2

Exclusion Criteria:

  • have any medical conditions that prevent participant from safely taking part in physical activity
  • currently a smoker
  • are pregnant, breastfeeding, or plan to become pregnant
  • have visited fitness centers more than eight times in the past two months
  • exercise outside of fitness centers more than once a week for one hour at a time in the past month
  • do not engage in more than 14 hours a week of screen-based activities
  • do not have a primarily sedentary job

Sites / Locations

  • USDA Grand Forks Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exercise-only intervention

Control intervention

Arm Description

Participants will receive information regarding the health benefits of regular aerobic and resistance training exercise and current physical activity guidelines for adults.

Participants will receive information regarding the health risks of chronic stress as well as suggested methods to reduce stress.

Outcomes

Primary Outcome Measures

Fitness center attendance
Change in fitness center attendance as measured by number of visits per week

Secondary Outcome Measures

Full Information

First Posted
March 29, 2018
Last Updated
January 18, 2022
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03498781
Brief Title
Good Intentions Study
Official Title
The Impact of Multiple Behavior Change on the Effectiveness of Implementation Intentions to Promote Fitness Center Visitation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of interest in pool of potential participants
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time.
Detailed Description
The purpose of this study is to investigate attendance, exercise, and screen time habits in fitness center members. Because they are the population under investigation, recruitment will take place via the fitness center facilities. This population is under investigation because much of this population is sedentary and does not exercise at recommended levels, despite access to physical fitness facilities. This research will investigate methods to encourage physical activity in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Exercise

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This study will be a between group factorial design. The between subjects variable will be group assignment. The within subjects variable will be time.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise-only intervention
Arm Type
Experimental
Arm Description
Participants will receive information regarding the health benefits of regular aerobic and resistance training exercise and current physical activity guidelines for adults.
Arm Title
Control intervention
Arm Type
Sham Comparator
Arm Description
Participants will receive information regarding the health risks of chronic stress as well as suggested methods to reduce stress.
Intervention Type
Other
Intervention Name(s)
Exercise-only
Intervention Description
Participants will write goals related to exercise, the most desired outcome of reaching their goals, anticipated obstacles/barriers which may prevent them from achieving their goals, and if-then statements proactively describing how to overcome or avoid obstacles.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants will be asked to identify stress-reduction techniques which they can use in their daily lives and will be encouraged to practice them as necessary.
Primary Outcome Measure Information:
Title
Fitness center attendance
Description
Change in fitness center attendance as measured by number of visits per week
Time Frame
Week 0, 8, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index from 18-45 kg/m2 Exclusion Criteria: have any medical conditions that prevent participant from safely taking part in physical activity currently a smoker are pregnant, breastfeeding, or plan to become pregnant have visited fitness centers more than eight times in the past two months exercise outside of fitness centers more than once a week for one hour at a time in the past month do not engage in more than 14 hours a week of screen-based activities do not have a primarily sedentary job
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Roemmich, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Good Intentions Study

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