Obesity
Conditions
Brief summary
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 people living with obesity in Louisiana. The main questions it aims to answer are: * Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in Louisiana communities achieve weight loss at 6 months compared to enhanced usual care? * Will LA-CEAL CONNECT sustain weight loss at 12 months? * Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months? * Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in Louisiana communities? 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: * Receive health literacy-tailored educational materials and resources for weight loss * Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements Participants in the CONNECT intervention arm will also: * receive health coaching * self-monitor weight and physical activity using digital technologies * attend group meetings to identify and increase utilization of community health and wellness resources
Interventions
BEHAVIORALHealth Literacy and Culturally Tailored Materials
Participants will receive health literacy-appropriate written information on community resources and weight management
BEHAVIORALCommunity-Engaged Health Coaching and Navigation
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.
BEHAVIORALSelf-Monitoring and Remote Patient Monitoring of weight and physical activity
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.
OTHERCommunity Asset Mapping (CAM)
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.
OTHERPrimary Care Provider Training
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.
OTHERObesity Toolkit for Primary Care Providers
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.
Sponsors
Tulane University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* being 18 to 75 years of age * living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asian identifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifying participants * weighing less than 400 pounds * receiving care from or willing to register at a participating FQHC clinic * able to understand and speak English * able to complete the study within the next year (e.g., not planning to move from the area within study period)
Exclusion criteria
* having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year) * currently participating in a weight-loss program * having lost more than 10 pounds in the last 6 months * being an employee or a family member of an employee of any participating FQHC * having a disease that can interfere with or be aggravated by exercise or weight loss
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-group difference in % weight change | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-group difference in change in physical activity | 6 months | 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. |
| Between-group difference in change in quality of life | 6 months | 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. |
| Between-group difference in change in waist circumference | 6 months | 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. |
| Between-group difference in change in blood pressure | 6 months | 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. |
| Between-group difference in change in dietary intake | 6 months | 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. |
Countries
United States
Contacts
CONTACTLaura Perry, PhD
CONTACTErin Peacock, PhD, MPH
PRINCIPAL_INVESTIGATORMarie Krousel-Wood, MD, MSPH
Tulane University
Outcome results
None listed