Overweight and ObesityNCT02480244
PASOS: Improving the Health of Immigrant Workers
A study testing Behavioral Intervention in people with Overweight and Obesity and Diabetes, run by University of California, Davis at 1 site in United States.
Trial summary
This is a cluster randomized trial (CRT) 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. Randomization is at the farm ranch level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Diabetes
- 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
- 554 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 2 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Work at Reiter Brothers Inc. (RBI), a partner, or affiliate company
- Able to speak and understand Spanish
- Willing to attend weekly sessions for length of intervention
- Plan to stay in the area for the next three months
Who cannot join
- Workers without Spanish language comprehension
- Pregnant women and those planning a pregnancy within six months
- Women who are breastfeeding, unless discontinuing breastfeeding within one month
- Individuals who, without health care provider approval, are: unable to undertake moderate physical exercise, taking medicine for high blood pressure or heart conditions, have bone or joint problems, lose consciousness or fall due to dizziness, or have developed chest pain within the last month
- Individuals taking medications that affect weight
- Individuals with therapeutic diets
- Diabetic status determined by health care professional after HbA1c testing result is >6.5%
- If spouse / cohabitant is already in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
This is a cluster randomized trial (CRT) 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. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.
- Conditions
- Overweight and Obesity, Diabetes
- Being tested
- Behavioral Intervention, Control
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus
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 attend up to 12 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions are conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support are 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.
ControlOther
Control arm receives no health-related behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity Receives: Behavioral: Behavioral Intervention |
| Control | Active comparator | Control arm receives no health-related behavioral intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.
Measured: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Secondary outcomes (6)
Change in waist circumference
Waist circumference will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Change in hemoglobin A1c (HbA1c)
HbA1c will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in cholesterol
Cholesterol will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in behavior and lifestyle factors
Change in behavior and lifestyle factors will be assessed concurrently for control and intervention participants on matched ranches using a questionnaire comprised of validated measures.
Measured: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Cost analysis
Assessment of intervention's impact on employer costs.
Measured: Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.
Change in blood pressure
Change in blood pressure will be assessed concurrently for control and intervention participants on matched ranches using a standard protocol.
Measured: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Schenker, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480244
- Sponsor's protocol ID
- 575576
- Other IDs
- R18DK096429
- Status last verified
- Aug 2020
- First submitted
- 9 Jun 2015
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Borelli MR, Riden HE, Bang H, Schenker MB. Protocol for a cluster randomized controlled trial to study the effectiveness of an obesity and diabetes intervention (PASOS) in an immigrant farmworker population. BMC Public Health. 2018 Jul 9;18(1):849. doi: 10.1186/s12889-018-5560-0.
PubMed 29986676
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Obesity and Diabetes Prevention Into the Worksite for Immigrant Populations
- ClinicalTrials.gov ID
- NCT02480244
- Acronym / sponsor ID
- 575576
- Conditions
- Overweight and Obesity, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2015 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 24 Jun 2015 (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 cluster randomized trial (CRT) 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. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Behavioral InterventionBehavioral intervention consisting of 12 educational sessions promoting healthy diet and increased physical activity |
| Control | Active comparator | Other: ControlControl arm receives no health-related behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Work at Reiter Brothers Inc. (RBI), a partner, or affiliate company
- Able to speak and understand Spanish
- Willing to attend weekly sessions for length of intervention
- Plan to stay in the area for the next three months
Key exclusion criteria (8 listed)
- Workers without Spanish language comprehension
- Pregnant women and those planning a pregnancy within six months
- Women who are breastfeeding, unless discontinuing breastfeeding within one month
- Individuals who, without health care provider approval, are: unable to undertake moderate physical exercise, taking medicine for high blood pressure or heart conditions, have bone or joint problems, lose consciousness or fall due to dizziness, or have developed chest pain within the last month
- Individuals taking 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 attend up to 12 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions are conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support are 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 |
| ControlControl arm receives no health-related behavioral intervention | Other | Control |
Primary outcome
Change in BMI
Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Weight and height will be assessed at each data collection point and concurrently for control and intervention participants on matched ranches.
6 secondary outcomes
Change in waist circumference
Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
Change in hemoglobin A1c (HbA1c)
Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in cholesterol
Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Change in behavior and lifestyle factors
Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 1 year post-intervention.
Cost analysis
Time frame: Quarterly beginning a year prior to implementation of the intervention and concluding 1.5 years post-intervention.
Change in blood pressure
Time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.
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 7 Aug 2020.
- Derived from this study: PubMed 29986676Borelli MR, Riden HE, Bang H, Schenker MB. Protocol for a cluster randomized controlled trial to study the effectiveness of an obesity and diabetes intervention (PASOS) in an immigrant farmworker population. BMC Public Health. 2018 Jul 9;18(1):849. doi: 10.1186/s12889-018-5560-0.
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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 Schenker, MD, MPH principal investigator
University of California, Davis
1 site 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 and Diabetes, run by University of California, Davis 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 4 inclusion and 8 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 7 Aug 2020. 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 BMI (time frame: Measured at baseline prior to the intervention; immediately following the intervention (12 weeks after first assessment) and again at 6 months, 1 year, and 1.5 years post-intervention.). 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 NCT02480244, 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 7 Aug 2020.