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Healthy Body Healthy Souls: Weight Loss Intervention for Marshallese

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03377244
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The study aim is to pilot test and compare the effectiveness of achieving weight loss between implementation of: 1) the Diabetes Prevention Program Lifestyle Intervention (DPP-LI) and 2) Healthy Bodies Healthy Souls (HBHS) intervention which includes the same DPP-LI with the additional enhancement of working with Marshallese churches to implement organizational/institutional level changes to support the individual behavioral intervention of the DPP-LI.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Diabetes Prevention Program Lifestyle Intervention (DPP-LI) with Healthy Bodies Healthy Souls (HBHS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Our aim is to pilot test a weight-loss intervention referred to throughout the proposal as Healthy Bodies Healthy Souls (HBHS) in a single arm study. The intervention includes the Diabetes Prevention Program Lifestyle Intervention (DPP-LI) with the additional enhancement of working with Marshallese churches to implement organizational/institutional level changes to support the individual behavioral intervention of the DPP-LI.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : September 30, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy Bodies, Healthy Souls intervention
Participants in Diabetes Prevention Program Lifestyle Intervention (DPP-LI) with Healthy Bodies Healthy Souls (HBHS) intervention which includes the enhancement of working with Marshallese churches to implement organizational/institutional level changes to support the individual behavioral intervention of the DPP-LI.
Behavioral: Diabetes Prevention Program Lifestyle Intervention (DPP-LI) with Healthy Bodies Healthy Souls (HBHS)
Diabetes Prevention Program Lifestyle Intervention (DPP-LI) with Healthy Bodies Healthy Souls (HBHS) intervention which includes DPP-LI with the additional enhancement of working with Marshallese churches to implement organizational/institutional level changes to support the individual behavioral intervention of the DPP-LI.




Primary Outcome Measures :
  1. Change in mean percent body weight (pounds) loss [ Time Frame: 12 months ]
    Change in mean percent body weight (pounds) loss 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.


Secondary Outcome Measures :
  1. Change in mean HbA1c (%) [ Time Frame: 12 months ]
    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.

  2. Change in mean blood pressure (mmHg) [ Time Frame: 12 months ]
    Change in mean blood pressure (systolic and diastolic, 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.

  3. Change in eating habits self-efficacy [ Time Frame: 12 months ]
    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 (WEL) Questionnaire (Clark MM, Abrams DB, Niaura RS, et al. Self-efficacy in weight management. J Consult Clin Psychol. 1991;59(5):739-744). 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.

  4. Change in physical activity self-efficacy [ Time Frame: 12 months ]
    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 (SEE) Scale (Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000;49(3):154-159. & Resnick 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 Measurement. 2004; 12(3):235-247.) 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.

  5. Change in percentage of participants engaging in recommended levels of physical activity over the past month [ Time Frame: 12 months ]
    Change in percentage of participants engaging in recommended levels of physical activity from baseline to 6 months post-intervention (12 months post-initiation of the intervention). This self-report measure assessed participants' frequency of engaging in moderate and vigorous levels of physical activity over the past month (more than 4 times a week, 2-4 times a week, about once a week, etc.), and compares physical activity of the past month to participants' "usual phsyical activity level." This 3-question measure was slightly adapted to include relevant cultural examples of physical activity from the DASH 2 Brief Physical Activity Questionnaire (available here: https://biolincc.nhlbi.nih.gov/media/studies/dashsodium/Forms_Manual.pdf?link_time=2018-11-13_18:06:05.776099).

  6. Change in participants' sugar-sweetened beverage consumption [ Time Frame: 12 months ]
    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).

  7. Change in participants' fruit and vegetable consumption [ Time Frame: 12 months ]
    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 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;6(5):355-361.

  8. Change in perceived family support for exercise and dietary habits [ Time Frame: 12 months ]
    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 KJ. Social support for exercise and dietary habits among college students. Adolescence. 2008;43(171):557-575. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Self-reported Marshallese
  2. 18 years of age or older
  3. Have a body mass index (BMI) of ≥25 kg/m2

Exclusion Criteria:

  1. A clinically significant medical condition likely to impact weight (cancer, HIV/AIDS, etc.)
  2. Currently pregnant or breastfeeding an infant who is 6 months old or younger.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377244


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, United States, 72703
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Pearl McElfish, PhD, MBA University of Arkansas
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03377244    
Other Study ID Numbers: 217566
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes