Overweight and ObesityPasosNCT01855282
Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers
A study testing Behavioral Intervention in people with Overweight and Obesity, run by University of California, Davis at 2 sites in United States.
Trial summary
This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Apr 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 -60
- BMI between 20 -38
- Willing to attend 10 weekly education sessions
- Able to speak and understand Spanish
- Have medical insurance
Who cannot join
- Fasting blood glucose about 126mg/dL unless physician attests fit to participate
- Pregnancy or trying to conceive, or breastfeeding
- Diabetic
- On therapeutic diets
- On medications that affect weight
- If spouse / cohabitant already in the study
- Not a farm worker working for the Reiter Affiliated Companies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reiter Affiliated Companies
Oxnard, California, 93030
Reiter Affiliated Companies
Watsonville, California, 95076
About this study
Official title: Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.
Read the detailed description
A more detailed description is not desired as noted above.
- Conditions
- Overweight and Obesity
- Being tested
- Behavioral Intervention
- Keywords
- Diabetes Type II,, Overweight,, Obesity,, Behavioral Intervention,, Latino, farm worker, randomized controlled intervention
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Healthy Lifestyle intervention, Diet and Physical Activity intervention
Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity. Receives: Behavioral: Behavioral Intervention |
| Control | Active comparator | Control arm received no behavioral intervention Receives: Behavioral: Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.
Measured: Before intervention and after (12-14 weeks after first assessment)
Secondary outcomes (1)
Change in Waist Circumference
Waist circumference measured in both control and intervention participants using a standard protocol. Conducted before intervention started and again 2-3 weeks after the intervention sessions finished.
Measured: Measured before and after intervention (12 - 13 weeks after first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc B Schenker, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855282
- Sponsor's protocol ID
- 219631
- Other IDs
- S-MSPREIT
- Acronym
- Pasos
- Status last verified
- May 2017
- First submitted
- 8 May 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mitchell DC, Andrews T, Schenker MB. Pasos Saludables: A Pilot Randomized Intervention Study to Reduce Obesity in an Immigrant Farmworker Population. J Occup Environ Med. 2015 Oct;57(10):1039-46. doi: 10.1097/JOM.0000000000000535.
PubMed 26461858
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
- ClinicalTrials.gov ID
- NCT01855282
- Acronym / sponsor ID
- Pasos / 219631
- Conditions
- Overweight and Obesity
- Keywords
- Diabetes Type II,, Overweight,, Obesity,, Behavioral Intervention,, Latino, farm worker, randomized controlled intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 16 May 2013 (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 is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.
Detailed description
A more detailed description is not desired as noted above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Behavioral InterventionBehavioral intervention consisting of 10 educational sessions promoting healthy diet and increased physical activity. |
| Control | Active comparator | Behavioral: Behavioral InterventionControl arm received no behavioral intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 -60
- BMI between 20 -38
- Willing to attend 10 weekly education sessions
- Able to speak and understand Spanish
- Have medical insurance
Key exclusion criteria (7 listed)
- Fasting blood glucose about 126mg/dL unless physician attests fit to participate
- Pregnancy or trying to conceive, or breastfeeding
- Diabetic
- On therapeutic diets
- On medications that affect weight
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 |
|---|---|---|
| Behavioral InterventionAlso: Healthy Lifestyle intervention, Diet and Physical Activity interventionIntervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials. | Behavioural | Behavioral intervention, Control |
Primary outcome
Change in BMI
Time frame: Before intervention and after (12-14 weeks after first assessment)
Weight and Height assessed for both control and intervention participants before intervention program and then assessed 2-3 weeks after the intervention period completed.
1 secondary outcome
Change in Waist Circumference
Time frame: Measured before and after intervention (12 - 13 weeks after first assessment
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 15 May 2017.
- Derived from this study: PubMed 26461858Mitchell DC, Andrews T, Schenker MB. Pasos Saludables: A Pilot Randomized Intervention Study to Reduce Obesity in an Immigrant Farmworker Population. J Occup Environ Med. 2015 Oct;57(10):1039-46. doi: 10.1097/JOM.0000000000000535.
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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.
Marc B Schenker, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention in people with Overweight and Obesity, run by University of California, Davis at 2 sites 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 5 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: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 BMI (time frame: Before intervention and after (12-14 weeks after first assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855282, which also lists 1 linked publication.
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 15 May 2017.