Weight LossNCT03377244
Healthy Body Healthy Souls in the Marshallese Population
A study testing HBHS, HBHS Policy and WORD DPP in people with Weight Loss and Pre Diabetes, run by University of Arkansas at 1 site in United States.
Trial summary
The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Pre Diabetes, Overweight and Obesity
- What is being tested?
- HBHS, HBHS Policy and WORD DPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Self-reported Marshallese
- 18 years of age or older
- To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m^2
Who cannot join
- A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
- Currently pregnant or breastfeeding an infant who is 6 months old or younger.
- Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, and inability to finish the intervention, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
Official title: Healthy Body Healthy Souls: A Weight Loss Intervention Using Diabetes Prevention Program Lifestyle Intervention (DPP-LI) With Church Level Systems Change in the Marshallese Population
The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the individual level, with the additional enhancement of working with Marshallese churches to implement church-level changes to support the individual behavioral intervention of the WORD DPP. We will then compare changes in outcomes with participants in the churches who were exposed to the policy changes but did not participate in the WORD DPP, and with those enrolled in a separate DPP trial who participated in the WORD DPP but were not exposed to church-level policy changes.
Read the detailed description
Background and Rationale
Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders.
This study focuses on the Marshallese living in Arkansas. The Marshallese are a Pacific Islander population experiencing significant health disparities, with some of the highest documented rates of type 2 diabetes of any population group in the world. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (in the US and the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8% for the US population and 4% worldwide.
While national prevalence data are limited, 23.7% of Pacific Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a diagnosis of type 2 diabetes - more than all other racial/ethnic groups. Our preliminary research, which included health screenings with the Marshallese community in Northwest Arkansas (n = 401), documented extremely high incidence of diabetes (38.2%) and pre-diabetes (32.4%). Our pilot data also revealed similar disparities in obesity, one of the strongest risk factors for diabetes; 90% of Marshallese participants were classified as overweight or obese. Further compounding these significant disparities, Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventive or diagnostic treatment or diabetes education.
This study addresses an urgent need for interventions to reduce obesity and diabetes disparities in the Marshallese community and will employ a culturally appropriate, multilevel approach. The scientific premise of our study includes four main points. First, the Marshallese in Arkansas suffer from a significant and disproportionate burden of type 2 diabetes and lack access to effective prevention and treatment due to a dearth of research with Pacific Islanders.Second, the association between weight gain and risk for type 2 diabetes is strong. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) is clinically meaningful. Third, research demonstrates the effectiveness of multi-level lifestyle interventions in reducing weight and the onset and impact of diabetes. Fourth, to be effective among Pacific Islanders, interventions must be developed to address influences at multiple levels and should be culturally adapted to incorporate Pacific Islanders' worldviews and cultural values. Prior research indicates the importance of using a Community Based Participatory Research (CBPR) approach to understand and integrate cultural nuances during the cultural adaptation process and implementation of multilevel interventions. A CBPR approach is also essential to conducting ethical, valid health research in populations whose health beliefs and behaviors have been shaped by historical trauma. Finally, churches are primary social institutions of Pacific Islander health. Faith-based interventions are effective at improving behavioral and anthropometric outcomes within collectivistic communities and therefore hold great promise for Marshallese and other Pacific Islanders.
- Conditions
- Weight Loss, Pre Diabetes, Overweight and Obesity
- Being tested
- HBHS, HBHS Policy, WORD DPP
- Keywords
- Marshallese, Pacific Islanders
- Medical subject headings
- Weight Loss, Glucose Intolerance, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBHSBehavioural
Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
HBHS PolicyBehavioural
Church-level policy changes that encourages participants to engage in healthy behaviors.
WORD DPPBehavioural
Faith based diabetes curriculum that teaches participants to connect faith and health.
| Study group | Role | What they receive |
|---|---|---|
| HBHS | Experimental | Participants in the Healthy Bodies Healthy Souls (HBHS) arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities. Receives: Behavioral: HBHS |
| HBHS Policy | Active comparator | Participants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities. Receives: Behavioral: HBHS Policy |
| WORD DPP | Other | Participants in the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Receives: Behavioral: WORD DPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Body Weight (Pounds) Change
Mean percent body weight (pounds) change from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb using a calibrated digital scale.
Measured: Baseline, 6 months post-intervention
Secondary outcomes (9)
Change in Mean HbA1c (%)
Change in mean HbA1c (NGSP %) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant.
Measured: Baseline, 6 months post-intervention
Change in Mean Systolic Blood Pressure (mmHg)
Change in mean systolic blood pressure (mmHg) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Blood pressure was measured with a sphygmomanometer, with participants seated.
Measured: Baseline, 6 months post-intervention
Change in Mean Diastolic Blood Pressure (mmHg)
Change in mean diastolic blood pressure (mmHg) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Blood pressure was measured with a sphygmomanometer, with participants seated.
Measured: Baseline, 6 months post-intervention
Change in Eating Habits Self-Efficacy
Change in eating habits self-efficacy from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy related to their ability to make healthy eating decisions in the face of real or perceived barriers (e.g. while at social events, while watching TV, etc.). This 7-item measure was adapted from items in the original Weight Efficacy Life-Style Questionnaire by Clark et al (1991) (reference provided in the References in the Protocol Section). Each of the 7 items are measured via 3 response options ("Yes/Completely Sure"=2; "Maybe/Not Sure"=1; and "No/Not Sure at All"=0), giving a possible range of scores of 0-14, with higher scores indicating higher self-efficacy for making healthy eating decisions in spite of barriers.
Measured: Baseline, 6 months post-intervention
Change in Physical Activity Self-Efficacy
Change in physical activity self-efficacy from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' self-efficacy for exercising in the face of real or perceived barriers (e.g., bad weather, exercising alone, etc.). This 9-item measure was adapted from the Self-Efficacy for Exercise Scale by Resnick \& Jenkins (2000) and Resnick et al (2004) (references provided in the References in the Protocol Section). Each of the 9 items are measured via 3 response options ("Yes/Completely Sure"=2; "Maybe/Not Sure"=1; and "No/Not Sure at All"=0), giving a possible range of scores of 0-18, with higher scores indicating higher self-efficacy for exercising despite barriers.
Measured: Baseline, 6 months post-intervention
Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month
Change in percentage of participants engaging in sufficient levels of physical activity (PA) from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' frequency of engaging in both moderate and vigorous levels of physical activity over the past month with two items. Both items used a 4-point response scale: 1) Rarely or Never; 2) Once a week; 3) 2-4 times a week; and 4) More than 4 times a week. Each 4-point scale for moderate PA and vigorous PA was weighted: 0=Rarely or Never; 1=Once a week; 2=2-4 times a week; and 4=More than 4 times a week. The weights were then summed and dichotomized as follows: ≥4 = sufficient PA and <4 = insufficient PA. Items were adapted to include relevant cultural examples of physical activity from the DASH 2 Brief Physical Activity Questionnaire (link to original items provided in the References in the Protocol Section).
Measured: Baseline, 6 months post-intervention
Change in Sugar-Sweetened Beverage Consumption
Change in participants' sugar-sweetened beverage consumption from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' sugar-sweetened beverage consumption over the past 30 days using two questions from 'Module 14: Sugar Sweetened Beverages' of the CDC's Behavioral Risk Factor Surveillance System (BRFSS). Participants could respond in number of times per day, per week, or per month. Responses for each question were converted to number of times per day (i.e., self-reported times per week divided by 7 or self-reported times per month divided by 30), resulting in two measures: number times soda was consumed per day and number of times sugar-sweetened fruit drinks, sweet tea, and sports drinks were consumed per day. Per BRFSS guidelines, these two measures were added together to create a total daily SSB consumption rate.
Measured: Baseline, 6 months post-intervention
Change in Fruit and Vegetable Consumption
Change in participants' fruit and vegetable consumption from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' fruit and vegetable consumption over the past three months using three questions adapted from: Shannon et al (1997) (reference provided in the References in the Protocol Section). Each of the three items was scored as Often=2; Sometimes=1; Never=0. Items were summed to create a scale score, giving a possible range of scores of 0-6, with higher scores indicating more frequent consumption of fruit and vegetables.
Measured: Baseline, 6 months post-intervention
Change in Perceived Family Support for Exercise and Dietary Habits
Change in perceived family support for exercise and dietary habits from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure was adapted to examine changes in perceived family support for engaging in healthy exercise and dietary habits. This measure consists of a 6-item scale adapted from: Gruber (2008) (reference provided in the References in the Protocol Section). Each of the 6 items are measured via 3 response options ("Often"=2; "Sometimes"=1; and "Never"=0), giving a possible range of scores of 0-12, with higher scores indicating higher perceived family support for exercising and eating healthier.
Measured: Baseline, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start30 Sep 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Our aim is to pilot test a multi-level weight-loss intervention in the Marshallese community. Changes in outcomes were examined from baseline to 6 months post-intervention (12 months post-initiation of the intervention).
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pearl McElfish, PhD, MBA, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377244
- Sponsor's protocol ID
- 217566
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2017
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997 May;6(5):355-61.
PubMed 9149896Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008 Fall;43(171):557-75.
PubMed 19086670Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.
PubMed 1955608Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.
PubMed 10882320Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the self-efficacy for exercise and outcome expectations for exercise scales with minority older adults. J Nurs Meas. 2004 Winter;12(3):235-47. doi: 10.1891/jnum.12.3.235.
PubMed 16138727
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Body Healthy Souls: A Weight Loss Intervention Using Diabetes Prevention Program Lifestyle Intervention (DPP-LI) With Church Level Systems Change in the Marshallese Population
- ClinicalTrials.gov ID
- NCT03377244
- Acronym / sponsor ID
- 217566
- Conditions
- Weight Loss, Pre Diabetes, Overweight and Obesity
- Keywords
- Marshallese, Pacific Islanders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to pilot test a weight-loss intervention for Marshallese adults, referred to throughout as Healthy Bodies Healthy Souls (HBHS). The HBHS intervention includes the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) implemented at the individual level, with the additional enhancement of working with Marshallese churches to implement church-level changes to support the individual behavioral intervention of the WORD DPP. We will then compare changes in outcomes with participants in the churches who were exposed to the policy changes but did not participate in the WORD DPP, and with those enrolled in a separate DPP trial who participated in the WORD DPP but were not exposed to church-level policy changes.
Detailed description
Background and Rationale
Disparities in type 2 diabetes, pre-diabetes, and obesity among the Marshallese and Pacific Islanders.
This study focuses on the Marshallese living in Arkansas. The Marshallese are a Pacific Islander population experiencing significant health disparities, with some of the highest documented rates of type 2 diabetes of any population group in the world. Our review of local, national, and international data sources found estimates of diabetes in the Marshallese population (in the US and the Republic of the Marshall Islands) ranging from 20% to 50%, compared to 8% for the US population and 4% worldwide.
While national prevalence data are limited, 23.7% of Pacific Islanders surveyed by the Centers for Disease Control and Prevention (CDC) in 2010 reported a diagnosis of type 2 diabetes - more than all other racial/ethnic groups. Our preliminary research, which included health screenings with the Marshallese community in Northwest Arkansas (n = 401), documented extremely high incidence of diabetes (38.2%) and pre-diabetes (32.4%). Our pilot data also revealed similar disparities in obesity, one of the strongest risk factors for diabetes; 90% of Marshallese participants were classified as overweight or obese. Further compounding these significant disparities, Pacific Islanders living in the US are less likely than other racial/ethnic groups to receive preventive or diagnostic treatment or diabetes education.
This study addresses an urgent need for interventions to reduce obesity and diabetes disparities in the Marshallese community and will employ a culturally appropriate, multilevel approach. The scientific premise of our study includes four main points. First, the Marshallese in Arkansas suffer from a significant and disproportionate burden of type 2 diabetes and lack access to effective prevention and treatment due to a dearth of research with Pacific Islanders.Second, the association between weight gain and risk for type 2 diabetes is strong. Overweight/obesity is considered the strongest modifiable risk factor for type 2 diabetes, and even a modest reduction in weight (5-10%) is clinically meaningful. Third, research demonstrates the effectiveness of multi-level lifestyle interventions in reducing weight and the onset and impact of diabetes. Fourth, to be effective among Pacific Islanders, interventions must be developed to address influences at multiple levels and should be culturally adapted to incorporate Pacific Islanders' worldviews and cultural values. Prior research indicates the importance of using a Community Based Participatory Research (CBPR) approach to understand and integrate cultural nuances during the cultural adaptation process and implementation of multilevel interventions. A CBPR approach is also essential to conducting ethical, valid health research in populations whose health beliefs and behaviors have been shaped by historical trauma. Finally, churches are primary social institutions of Pacific Islander health. Faith-based interventions are effective at improving behavioral and anthropometric outcomes within collectivistic communities and therefore hold great promise for Marshallese and other Pacific Islanders.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Our aim is to pilot test a multi-level weight-loss intervention in the Marshallese community. Changes in outcomes were examined from baseline to 6 months post-intervention (12 months post-initiation of the intervention).
| Arm | Type | Receives |
|---|---|---|
| HBHS | Experimental | Behavioral: HBHSParticipants in the Healthy Bodies Healthy Souls (HBHS) arm received the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) with the addition of church-level policy changes to support the individual behavioral intervention of the WORD DPP. The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities. |
| HBHS Policy | Active comparator | Behavioral: HBHS PolicyParticipants in the HBHS Policy arm included members of churches enrolled in the HBHS study who did not receive the WORD DPP intervention (ie, these participants were exposed to only the church-level policy changes). Church-level changes to support healthier behaviors include improvements in food purchasing and preparation for events, physical activity programs, and increased congregational engagement in health promotion activities. |
| WORD DPP | Other | Behavioral: WORD DPPParticipants in the Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program Lifestyle Intervention (WORD DPP) arm included participants enrolled in a separate DPP study without the church-level policy changes (ie, these participants received only the WORD DPP intervention). The WORD DPP is a faith-based diabetes prevention curriculum that teaches participants to connect faith and health to have a healthy weight, eat healthy, and be physically active. The WORD DPP-LI includes 16 modules that are intended to be delivered over a 24 week period, each module approximately 90 minutes in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-reported Marshallese
- 18 years of age or older
- To participate in the DPP-LI, have a body mass index (BMI) of ≥25 kg/m^2
Key exclusion criteria (3 listed)
- A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
- Currently pregnant or breastfeeding an infant who is 6 months old or younger.
- Have any condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, plans to move out of the area within 6 months, and inability to finish the intervention, 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 |
|---|---|---|
| HBHSFaith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors. | Behavioural | HBHS |
| HBHS PolicyChurch-level policy changes that encourages participants to engage in healthy behaviors. | Behavioural | HBHS Policy |
| WORD DPPFaith based diabetes curriculum that teaches participants to connect faith and health. | Behavioural | WORD DPP |
Primary outcome
Mean Percent Body Weight (Pounds) Change
Time frame: Baseline, 6 months post-intervention
Mean percent body weight (pounds) change from baseline to 6 months post-intervention (12 months post-initiation of the intervention). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb using a calibrated digital scale.
9 secondary outcomes
Change in Mean HbA1c (%)
Time frame: Baseline, 6 months post-intervention
Change in Mean Systolic Blood Pressure (mmHg)
Time frame: Baseline, 6 months post-intervention
Change in Mean Diastolic Blood Pressure (mmHg)
Time frame: Baseline, 6 months post-intervention
Change in Eating Habits Self-Efficacy
Time frame: Baseline, 6 months post-intervention
Change in Physical Activity Self-Efficacy
Time frame: Baseline, 6 months post-intervention
Change in Percentage of Participants Engaging in Sufficient Levels of Physical Activity Over the Past Month
Time frame: Baseline, 6 months post-intervention
Change in Sugar-Sweetened Beverage Consumption
Time frame: Baseline, 6 months post-intervention
Change in Fruit and Vegetable Consumption
Time frame: Baseline, 6 months post-intervention
Change in Perceived Family Support for Exercise and Dietary Habits
Time frame: Baseline, 6 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9149896Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997 May;6(5):355-61.
- Background: PubMed 19086670Gruber KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008 Fall;43(171):557-75.
- Background: PubMed 1955608Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. J Consult Clin Psychol. 1991 Oct;59(5):739-44. doi: 10.1037//0022-006x.59.5.739.
- Background: PubMed 10882320Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.
- Background: PubMed 16138727Resnick B, Luisi D, Vogel A, Junaleepa P. Reliability and validity of the self-efficacy for exercise and outcome expectations for exercise scales with minority older adults. J Nurs Meas. 2004 Winter;12(3):235-47. doi: 10.1891/jnum.12.3.235.
- DASH 2 Brief Physical Activity Questionnaire (p. 116)Link provided by the sponsor.
- 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.
Pearl McElfish, PhD, MBA principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBHS, HBHS Policy and WORD DPP in people with Weight Loss and Pre Diabetes, run by University of Arkansas 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 3 inclusion and 3 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 29 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent Body Weight (Pounds) Change (time frame: Baseline, 6 months 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 NCT03377244, which also lists 5 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 29 Jan 2021.