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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in low-income and underserved people living with obesity in Louisiana. The main questions it aims to answer are:
Researchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care.
Participants in both arms will:
Participants in the CONNECT intervention arm will also:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LA-CEAL CONNECT Intervention | Experimental | Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit). Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community. FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management. |
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| Enhanced Usual Care | Active Comparator | Participants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Literacy and Culturally Tailored Materials | Behavioral | Participants will receive health literacy-appropriate written information on community resources and weight management |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in % weight change | Trained personnel will measure weight at all visits using a digital weight scale. For weight, measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.1 kg. An average of the two closest measurements will be used for analyses. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in change in waist circumference | Trained personnel will measure waist circumference at all study visits using a non-elastic tape measure placed on the skin in a horizontal plane around the abdomen at the level of the iliac crest. The measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.5 cm; average of the two closest measurements will be used for analyses. |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in % weight change | Change in weight from the baseline visit to the 12 month visit using a standard protocol (see above). | 12 months |
| Between-group difference in change in waist circumference |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Perry, PhD | Contact | 504-988-8906 | Lperry5@tulane.edu | |
| Erin Peacock, PhD, MPH | Contact | 504-988-1075 | epeacoc@tulane.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marie Krousel-Wood, MD, MSPH | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InclusivCare - Avondale Clinic | Recruiting | Avondale | Louisiana | 70094 | United States |
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| Community-Engaged Health Coaching and Navigation | Behavioral | Participants will receive virtual coaching sessions over a 6-month period from trained Community Health Workers (CHWs). Coaching will include culturally competent information and strategies for weight management, and linking participants to community wellness resources identified in Community Asset Mapping (see below). Coaches will also remotely monitor patients' weight loss and physical activity via online portals to provide patients with tailored support during coaching sessions. |
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| Self-Monitoring and Remote Patient Monitoring of weight and physical activity | Behavioral | Participants will self-monitor weight and physical activity during the 6-month health coaching protocol using a cellular-connected digital weight scale and a Bluetooth-connected wrist-worn fitness tracking device (e.g., Fitbit). Participants will be instructed to weigh themselves and wear a fitness tracker (e.g., Fitbit) daily. Health coaches will remotely monitor weight and physical activity data logged by these devices to incorporate into health coaching sessions. |
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| Community Asset Mapping (CAM) | Other | The CHW from each intervention community clinic will convene a team of community members, including but not limited to CONNECT participants, that will meet regularly to identify and describe community assets that enable, support, and promote healthy lifestyles related to weight loss and management (e.g., healthy eating and physical activity resources). Community teams will be supported to design and implement Community Action Projects to promote the utilization of community resources identified in the map. |
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| Primary Care Provider Training | Other | Education sessions will be provided to FQHC providers. The training curriculum is designed to increase healthcare providers' knowledge of evidence-based and guideline-concordant obesity management strategies in primary care settings. |
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| Obesity Toolkit for Primary Care Providers | Other | We will provide FQHC providers with a toolkit containing additional obesity management resources and information and the community resource guides given to participants to support obesity management. |
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| 6 months |
| Between-group difference in change in blood pressure | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured at every study visit using an oscillometric Omron Professional Intellisense Blood Pressure Monitor HEM-907XL and following the American Heart Association (AHA) protocol. | 6 months |
| Between-group difference in change in dietary intake | Diet will be self-reported at every study visit using a diet screener that has been developed by the study investigators and used in past studies. The screener will assess frequency of consumption of selected food and drinks over the past month - including fruits and vegetables, high-fat foods, and alcoholic beverages. | 6 months |
| Between-group difference in change in physical activity | Physical activity will be self-reported at every study visit using the 7-item international physical activity questionnaire - short form (IPAQ-SF). This tool records the time spent at 4 different activity levels (vigorous, moderate, walking, sitting) according to 7-day recall. Scores are computed by calculating total minutes/week or total MET-minutes/week spent in the following activity levels: vigorous, moderate, walking, sitting. A total physical activity score is computed by summing the values for vigorous, moderate, and walking domains. The minimum score is 0 (no activity), with higher scores indicating more physical activity. The categorical physical activity level (low, moderate, and high) will be calculated using cut points recommended by the authors. Continuous activity score may be used as a more sensitive measure of participant physical activity change. | 6 months |
| Between-group difference in change in quality of life | Quality of life will be self-reported at every study visit using the 10-item Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure. Raw scores for Global Physical Health and Global Mental health will be computed, ranging from 4 to 20. Per PROMIS scoring guidelines, raw scores will be transformed to a T-score metric, with higher scores representing better health on each domain. | 6 months |
Change in waist circumference from the baseline visit to the 12 month visit using a standard protocol (see above).
| 12 months |
| Between-group difference in change in blood pressure | Change in SBP and DBP from baseline visit to 12 month visit using a standard protocol (see above). | 12 months |
| Between-group difference in change in dietary intake | Diet will be self-reported at every study visit using a diet screener that has been developed by the study investigators and used in past studies. The screener will assess frequency of consumption of selected food and drinks over the past month - including fruits and vegetables, high-fat foods, and alcoholic beverages. | 12 months |
| Between-group difference in change in physical activity | Physical activity will be self-reported at every study visit using the 7-item international physical activity questionnaire - short form (IPAQ-SF). This tool records the time spent at 4 different activity levels (vigorous, moderate, walking, sitting) according to 7-day recall. Scores are computed by calculating total minutes/week or total MET-minutes/week spent in the following activity levels: vigorous, moderate, walking, sitting. A total physical activity score is computed by summing the values for vigorous, moderate, and walking domains. The minimum score is 0 (no activity), with higher scores indicating more physical activity. The categorical physical activity level (low, moderate, and high) will be calculated using cut points recommended by the authors. Continuous activity score may be used as a more sensitive measure of participant physical activity change. | 12 months |
| Between-group difference in change in quality of life | Quality of life will be self-reported at every study visit using the 10-item Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure. Raw scores for Global Physical Health and Global Mental health will be computed, ranging from 4 to 20. Per PROMIS scoring guidelines, raw scores will be transformed to a T-score metric, with higher scores representing better health on each domain. | 12 months |
| Between-group difference in fidelity | Composite measure of fidelity comprised of self-reported frequency of weight measurement, receipt of health coaching, and use of community resources that support healthy lifestyles. | 6 months |
| CommuniHealth Services - Bastrop Clinic | Recruiting | Bastrop | Louisiana | 71220 | United States |
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| CareSouth Medical and Dental - Baton Rouge Clinic | Recruiting | Baton Rouge | Louisiana | 70806 | United States |
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| Teche Action Clinic - Franklin | Recruiting | Franklin | Louisiana | 70538 | United States |
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| Southeast Community Health Systems - Greensburg Clinic | Recruiting | Greensburg | Louisiana | 70441 | United States |
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| Teche Action Clinic - Houma | Recruiting | Houma | Louisiana | 70360 | United States |
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| Southeast Community Health Systems - Independence Clinic | Recruiting | Independence | Louisiana | 70443 | United States |
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| InclusivCare - Kenner Clinic | Recruiting | Kenner | Louisiana | 70062 | United States |
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| RKM Primary Care - Loranger Clinic | Recruiting | Loranger | Louisiana | 70446 | United States |
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| InclusivCare - Marrero | Recruiting | Marrero | Louisiana | 70072 | United States |
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| David Raines Community Health Center - Minden Clinic | Recruiting | Minden | Louisiana | 71055 | United States |
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| Teche Action Clinic - Morgan City | Recruiting | Morgan City | Louisiana | 70380 | United States |
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| NOELA Community Health Center | Recruiting | New Orleans | Louisiana | 70129 | United States |
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| Teche Action Clinic - South Pierre Part | Recruiting | Pierre Part | Louisiana | 70339 | United States |
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| CareSouth Medical and Dental - Plaquemine Clinic | Recruiting | Plaquemine | Louisiana | 70764 | United States |
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| David Raines Community Health Center - Shreveport Clinic | Recruiting | Shreveport | Louisiana | 71107 | United States |
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| RKM Primary Care - Springfield Clinic | Recruiting | Springfield | Louisiana | 70462 | United States |
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| CommuniHealth Services - West Monroe Clinic | Recruiting | West Monroe | Louisiana | 71292 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057220 | Health Literacy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D054626 | Consumer Health Information |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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