ObesityNCT01093924
Partnerships to Overcome Obesity Disparities in Hawaii: 18-month CBPR Study
A study testing PILI 'Ohana 18-month weight loss maintenance in people with Obesity, run by University of Hawaii at 4 sites in United States.
Trial summary
This is a 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- PILI 'Ohana 18-month weight loss maintenance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Feb 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background;
- Age 18 years or older
- Overweight or Obese defined as BMI > 25 kg/m2 (NH or Pacific Islanders) or > 23 kg/m2 (Filipino ethnic background)
- Willing and able to follow a weight loss maintenance intervention program that could include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to maintain weight loss
- Able to identify at least one family, friend, or co-worker who would be willing to support the participant during the course of the study
Who cannot join
- Survival less than 6 months
- Planning to move out of the community during the intervention study period
- Pregnancy
- Any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e., end-stage renal disease on a renal diet, etc.)
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hawaii Maoli
Honolulu, Hawaii, 96807
Ke Ola Mamo
Honolulu, Hawaii, 96813
Kula no na Po'e Hawaii
Honolulu, Hawaii, 96816
Kokua Kalihi Valley
Honolulu, Hawaii, 96819
About this study
Official title: Partnerships to Overcome Obesity Disparities in Hawaii
This is a 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment.
Read the detailed description
Obesity and overweight are well recognized public health concerns in the US and the magnitude of excess weight is greater among racial/ethnic minority populations. For NHs and PPs 70 to 80% of adults are estimated to be overweight or obese. Obesity-related disparities such as diabetes and heart disease (CVD) are also increasing among NHs and PPs. To address obesity and related disparities, a community-based participatory research (CBPR) partnership was formed entitled, the Partnership for Improving Lifestyle Interventions (PILI) 'Ohana Program (Pili meaning relationship and 'Ohana meaning family). The PILI 'Ohana Program (POP) consists of 5 community organizations and the Department of Native Hawaiian Health (DNHH) at the John A. Burns School of Medicine (JABSOM) of the University of Hawai'i (UH). With a 3-year CBPR planning grant from the National Center on Minority Health and Health Disparities (NCMHD), the POP was successful at establishing this community-academic partnership aimed at obesity-related disparities in Hawai'i and in implementing a pilot intervention to address weight loss maintenance (the PILI 'Ohana Intervention) in NHs and PPs, which serves as preliminary data for this application. The specific aims are as follow: 1) To identify the aspects of the PILI 'Ohana (family + community focused) Intervention deemed effective by former participants and community-peer educators of the pilot intervention. 2) To test whether a face-to-face or DVD delivery method of the PILI 'Ohana intervention is effective in improving weight loss maintenance versus a control group in NHs and PPs. 3) To identify the strengths of the PILI 'Ohana Program that supports a co-learning and co-equal environment.
- Conditions
- Obesity
- Being tested
- PILI 'Ohana 18-month weight loss maintenance
- Keywords
- Behavioral weight loss maintenance intervention, Weight loss, Weight loss maintenance
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PILI 'Ohana 18-month weight loss maintenanceBehavioural
Also called PILI 'Ohana Partnership
All participants will receive a 8 lesson 3-month weight loss intervention. They will then be randomized. Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months. Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles. Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| self-guided weight loss maintenance | No intervention | 15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information. |
| DVD group | Experimental | 15-month weight loss maintenance intervention deliver via DVD. Receives: Behavioral: PILI 'Ohana 18-month weight loss maintenance |
| face-to-face group | Experimental | 15-month weight loss/weight loss maintenance intervention delivered in a group setting Receives: Behavioral: PILI 'Ohana 18-month weight loss maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Amount of Weight loss in kilograms from baseline to 18 month follow-up
Measured: 18-months
Secondary outcomes (5)
Systolic/diastolic blood pressure
Systolic/diastolic blood pressure (mmHg) as measured by an electronic blood pressure device
Measured: 18-months
Self-reported dietary fat intake
Self-reported dietary fat intake using an 18-item Food Frequency Questionnaire
Measured: 18-months
Self-reported physical activity
Self-reported physical activity frequency and intensity using a 3-item brief physical activity questionnaire
Measured: 18-months
Physical functioning
Physical functioning as measured by distance walked in feet via a 6-minunte Walk Test
Measured: 18-month
Self-reported health beliefs
Self-reported health beliefs associated with diet, physical activity, and weight using a standardized questionnaire
Measured: 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Joseph K Kaholokula, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093924
- Sponsor's protocol ID
- PILI 'Ohana 5 year
- Other IDs
- R24MD001660-04
- Status last verified
- Nov 2013
- First submitted
- 17 Mar 2010
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sinclair KA, Zamora-Kapoor A, Townsend-Ing C, McElfish PA, Kaholokula JK. Implementation outcomes of a culturally adapted diabetes self-management education intervention for Native Hawaiians and Pacific islanders. BMC Public Health. 2020 Oct 20;20(1):1579. doi: 10.1186/s12889-020-09690-6.
PubMed 33081736Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.
PubMed 23086589
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnerships to Overcome Obesity Disparities in Hawaii
- ClinicalTrials.gov ID
- NCT01093924
- Acronym / sponsor ID
- PILI 'Ohana 5 year
- Conditions
- Obesity
- Keywords
- Behavioral weight loss maintenance intervention, Weight loss, Weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Oct 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Mar 2010 (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 5-year community-based participatory research intervention study with the goals of 1) conducting a more definitive study of weight loss maintenance in Native Hawaiians and Pacific Peoples and 2) identifying the aspects of the community-academic partnership that fosters a co-learning and co-equal environment.
Detailed description
Obesity and overweight are well recognized public health concerns in the US and the magnitude of excess weight is greater among racial/ethnic minority populations. For NHs and PPs 70 to 80% of adults are estimated to be overweight or obese. Obesity-related disparities such as diabetes and heart disease (CVD) are also increasing among NHs and PPs. To address obesity and related disparities, a community-based participatory research (CBPR) partnership was formed entitled, the Partnership for Improving Lifestyle Interventions (PILI) 'Ohana Program (Pili meaning relationship and 'Ohana meaning family). The PILI 'Ohana Program (POP) consists of 5 community organizations and the Department of Native Hawaiian Health (DNHH) at the John A. Burns School of Medicine (JABSOM) of the University of Hawai'i (UH). With a 3-year CBPR planning grant from the National Center on Minority Health and Health Disparities (NCMHD), the POP was successful at establishing this community-academic partnership aimed at obesity-related disparities in Hawai'i and in implementing a pilot intervention to address weight loss maintenance (the PILI 'Ohana Intervention) in NHs and PPs, which serves as preliminary data for this application. The specific aims are as follow: 1) To identify the aspects of the PILI 'Ohana (family + community focused) Intervention deemed effective by former participants and community-peer educators of the pilot intervention. 2) To test whether a face-to-face or DVD delivery method of the PILI 'Ohana intervention is effective in improving weight loss maintenance versus a control group in NHs and PPs. 3) To identify the strengths of the PILI 'Ohana Program that supports a co-learning and co-equal environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| self-guided weight loss maintenance | No intervention | –15-month self-guided weight loss maintenance group will receive monthly reminders to maintain their weight loss and newsletters that contain health information. |
| DVD group | Experimental | Behavioral: PILI 'Ohana 18-month weight loss maintenance15-month weight loss maintenance intervention deliver via DVD. |
| face-to-face group | Experimental | Behavioral: PILI 'Ohana 18-month weight loss maintenance15-month weight loss/weight loss maintenance intervention delivered in a group setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported Native Hawaiian, Filipino, or other Pacific Islander ethnic background;
- Age 18 years or older
- Overweight or Obese defined as BMI > 25 kg/m2 (NH or Pacific Islanders) or > 23 kg/m2 (Filipino ethnic background)
- Willing and able to follow a weight loss maintenance intervention program that could include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to maintain weight loss
- Able to identify at least one family, friend, or co-worker who would be willing to support the participant during the course of the study
Key exclusion criteria (5 listed)
- Survival less than 6 months
- Planning to move out of the community during the intervention study period
- Pregnancy
- Any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e., end-stage renal disease on a renal diet, etc.)
- Any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e., severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).
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 |
|---|---|---|
| PILI 'Ohana 18-month weight loss maintenanceAlso: PILI 'Ohana PartnershipAll participants will receive a 8 lesson 3-month weight loss intervention. They will then be randomized. Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months. Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles. Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention. | Behavioural | DVD group, face-to-face group |
Primary outcome
Weight loss
Time frame: 18-months
Amount of Weight loss in kilograms from baseline to 18 month follow-up
5 secondary outcomes
Systolic/diastolic blood pressure
Time frame: 18-months
Self-reported dietary fat intake
Time frame: 18-months
Self-reported physical activity
Time frame: 18-months
Physical functioning
Time frame: 18-month
Self-reported health beliefs
Time frame: 18-month
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 Nov 2013.
- Derived from this study: PubMed 33081736Sinclair KA, Zamora-Kapoor A, Townsend-Ing C, McElfish PA, Kaholokula JK. Implementation outcomes of a culturally adapted diabetes self-management education intervention for Native Hawaiians and Pacific islanders. BMC Public Health. 2020 Oct 20;20(1):1579. doi: 10.1186/s12889-020-09690-6.
- Derived from this study: PubMed 23086589Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1.
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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.
Joseph K Kaholokula, PhD principal investigator
University of Hawaii
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PILI 'Ohana 18-month weight loss maintenance in people with Obesity, run by University of Hawaii at 4 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 5 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 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Weight loss (time frame: 18-months). 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 NCT01093924, which also lists 2 linked publications.
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 Nov 2013.