NCT03498781

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

March 29, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

March 29, 2018

Last Update Submit

January 18, 2022

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Fitness center attendance

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

    Week 0, 8, 16

Study Arms (2)

Exercise-only intervention

EXPERIMENTAL

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

Other: Exercise-only

Control intervention

SHAM COMPARATOR

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

Other: Control

Interventions

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.

Exercise-only intervention
ControlOTHER

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.

Control intervention

Eligibility Criteria

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

You may qualify if:

  • Body mass index from 18-45 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • James Roemmich, PhD

    USDA Grand Forks Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: This study will be a between group factorial design. The between subjects variable will be group assignment. The within subjects variable will be time.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 17, 2018

Study Start

April 25, 2018

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations