ObesityNCT03498781
Good Intentions Study
A study testing Exercise-only in people with Obesity and Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Exercise-only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index from 18-45 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58203
About this study
Official title: The Impact of Multiple Behavior Change on the Effectiveness of Implementation Intentions to Promote Fitness Center Visitation
The purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Exercise-only, Control
- Keywords
- Exercise
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-onlyOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitness center attendance
Change in fitness center attendance as measured by number of visits per week
Measured: Week 0, 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start25 Apr 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Why it stopped: Lack of interest in pool of potential participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Grand Forks Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James Roemmich, PhD, Principal investigator, USDA Grand Forks Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498781
- Sponsor's protocol ID
- GFHNRC408
- Status last verified
- Jan 2022
- First submitted
- 29 Mar 2018
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multiple Behavior Change on the Effectiveness of Implementation Intentions to Promote Fitness Center Visitation
- ClinicalTrials.gov ID
- NCT03498781
- Acronym / sponsor ID
- GFHNRC408
- Conditions
- Obesity, Overweight
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of interest in pool of potential participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- USDA Grand Forks Human Nutrition Research CenterUS federal agency
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise-only intervention | Experimental | Other: Exercise-onlyParticipants will receive information regarding the health benefits of regular aerobic and resistance training exercise and current physical activity guidelines for adults. |
| Control intervention | Sham comparator | Other: ControlParticipants will receive information regarding the health risks of chronic stress as well as suggested methods to reduce stress. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index from 18-45 kg/m2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-onlyParticipants 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. | Other | Exercise-only intervention |
| ControlParticipants 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. | Other | Control intervention |
Primary outcome
Fitness center attendance
Time frame: Week 0, 8, 16
Change in fitness center attendance as measured by number of visits per week
Results and safety
The study was stopped early (reason given: Lack of interest in pool of potential participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Roemmich, PhD principal investigator
USDA Grand Forks Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-only in people with Obesity and Overweight, run by USDA Grand Forks Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of interest in pool of potential participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitness center attendance (time frame: Week 0, 8, 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.