ObesityNCT03028935
Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
A study testing Exercise Intervention and Nutritional Intervention in people with Obesity and Overweight, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Exercise Intervention and Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2016to 19 Mar 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase I:
- Bilingual Latina
- Live in the community
- Phase II:
- Latina
- Currently non-active (exercise two days or less per week)
- Overweight or obese (body mass index [BMI] of 24 or greater)
Who cannot join
- A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Fuerte y Sanas: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.
Read the detailed description
PRIMARY OBJECTIVES:
- Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.
II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.
OUTLINE:
Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.
Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).
INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.
- Conditions
- Obesity, Overweight
- Being tested
- Exercise Intervention, Nutritional Intervention
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo instructor-led exercise program
Nutritional InterventionBehavioural
Undergo instructor-led nutritional education program
| Study group | Role | What they receive |
|---|---|---|
| Prevention (exercise, nutrition education program) | Experimental | Exercise Intervention \& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks. Receives: Behavioral: Exercise Intervention; Behavioral: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Mean and standard deviation will be calculated.
Measured: Baseline up to post intervention, up to 7 months
Secondary outcomes (1)
Change in fitness level as assessed by the 6 minute walk test
The distance walked in 6 minutes will be recorded. Mean and standard deviation will be calculated.
Measured: Baseline up to post intervention, up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start5 Jul 2016
- Primary completion30 Jun 2017
- Study completion19 Mar 2018
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.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Cynthia Perry, OHSU Knight Cancer Institute
- Investigators
- Cynthia Perry, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028935
- Sponsor's protocol ID
- IRB00011637
- Other IDs
- NCI-2016-01321, IRB00011637, P30CA069533, R03CA197657
- Status last verified
- Jun 2018
- First submitted
- 22 Sep 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuerte y Sanas: Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas
- ClinicalTrials.gov ID
- NCT03028935
- Acronym / sponsor ID
- IRB00011637
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.
Detailed description
PRIMARY OBJECTIVES:
- Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.
II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.
OUTLINE:
Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.
Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).
INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (exercise, nutrition education program) | Experimental | Behavioral: Exercise Intervention, Behavioral: Nutritional InterventionExercise Intervention \& Nutritional Intervention. Participants undergo instructor-led exercise and nutrition education classes for 60 minutes twice a week for 12 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Phase I:
- Bilingual Latina
- Live in the community
- Phase II:
- Latina
Key exclusion criteria (2 listed)
- A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
- Pregnancy
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 InterventionUndergo instructor-led exercise program | Behavioural | Prevention (exercise, nutrition education program) |
| Nutritional InterventionUndergo instructor-led nutritional education program | Behavioural | Prevention (exercise, nutrition education program) |
Primary outcome
Change in weight
Time frame: Baseline up to post intervention, up to 7 months
Mean and standard deviation will be calculated.
1 secondary outcome
Change in fitness level as assessed by the 6 minute walk test
Time frame: Baseline up to post intervention, up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
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.
Cynthia Perry principal investigator
OHSU Knight Cancer Institute
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 Intervention and Nutritional Intervention in people with Obesity and Overweight, run by OHSU Knight Cancer Institute 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jun 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in weight (time frame: Baseline up to post intervention, up to 7 months). 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 26 Jun 2018.