ObesityCONNECTNCT06835686
Collaborative Multi-level Obesity Intervention Engaging Communities Trial
A study testing Health Literacy and Culturally Tailored Materials, Community-Engaged Health Coaching and Navigation and Self-Monitoring and Remote Patient Monitoring of weight and physical activity in people with Obesity, run by Tulane University at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Health Literacy and Culturally Tailored Materials, Community-Engaged Health Coaching and Navigation and Self-Monitoring and Remote Patient Monitoring of weight and physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 18 sitesUnited States
- Study dates
- 14 Mar 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
InclusivCare - Avondale Clinic
Avondale, Louisiana, 70094
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
CommuniHealth Services - Bastrop Clinic
Bastrop, Louisiana, 71220
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
CareSouth Medical and Dental - Baton Rouge Clinic
Baton Rouge, Louisiana, 70806
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
Teche Action Clinic - Franklin
Franklin, Louisiana, 70538
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
Southeast Community Health Systems - Greensburg Clinic
Greensburg, Louisiana, 70441
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
Teche Action Clinic - Houma
Houma, Louisiana, 70360
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
Southeast Community Health Systems - Independence Clinic
Independence, Louisiana, 70443
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
InclusivCare - Kenner Clinic
Kenner, Louisiana, 70062
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
RKM Primary Care - Loranger Clinic
Loranger, Louisiana, 70446
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
InclusivCare - Marrero
Marrero, Louisiana, 70072
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
David Raines Community Health Center - Minden Clinic
Minden, Louisiana, 71055
Laura Perry, 504-988-8906, Lperry5@tuane.edu
- Recruiting
Teche Action Clinic - Morgan City
Morgan City, Louisiana, 70380
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
NOELA Community Health Center
New Orleans, Louisiana, 70129
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
Teche Action Clinic - South Pierre Part
Pierre Part, Louisiana, 70339
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
CareSouth Medical and Dental - Plaquemine Clinic
Plaquemine, Louisiana, 70764
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
David Raines Community Health Center - Shreveport Clinic
Shreveport, Louisiana, 71107
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
RKM Primary Care - Springfield Clinic
Springfield, Louisiana, 70462
Laura Perry, 504-988-8906, Lperry5@tulane.edu
- Recruiting
CommuniHealth Services - West Monroe Clinic
West Monroe, Louisiana, 71292
Laura Perry, 504-988-8906, Lperry5@tulane.edu
About this study
Official title: LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Communities Trial (CONNECT)
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?
Read more
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
- Conditions
- Obesity
- Being tested
- Health Literacy and Culturally Tailored Materials, Community-Engaged Health Coaching and Navigation, Self-Monitoring and Remote Patient Monitoring of weight and physical activity, Community Asset Mapping (CAM), Primary Care Provider Training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy and Culturally Tailored MaterialsBehavioural
Participants will receive health literacy-appropriate written information on community resources and weight management
Community-Engaged Health Coaching and NavigationBehavioural
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.
Self-Monitoring and Remote Patient Monitoring of weight and physical activityBehavioural
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.
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.
Primary Care Provider TrainingOther
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.
Obesity Toolkit for Primary Care ProvidersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health Literacy and Culturally Tailored Materials; Behavioral: Community-Engaged Health Coaching and Navigation; Behavioral: Self-Monitoring and Remote Patient Monitoring of weight and physical activity; Other: Community Asset Mapping (CAM); Other: Primary Care Provider Training; Other: Obesity Toolkit for Primary Care Providers |
| 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. Receives: Behavioral: Health Literacy and Culturally Tailored Materials; Other: Primary Care Provider Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start14 Mar 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marie Krousel-Wood, MD, MSPH, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835686
- Sponsor's protocol ID
- 2024-822
- Other IDs
- OT2HL158287
- Acronym
- CONNECT
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Communities Trial (CONNECT)
- ClinicalTrials.gov ID
- NCT06835686
- Acronym / sponsor ID
- CONNECT / 2024-822
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 522 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 19 Feb 2025 (actual)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA-CEAL CONNECT Intervention | Experimental | Behavioral: Health Literacy and Culturally Tailored Materials, Behavioral: Community-Engaged Health Coaching and Navigation, Behavioral: Self-Monitoring and Remote Patient Monitoring of weight and physical activity, Other: Community Asset Mapping (CAM), Other: Primary Care Provider Training, Other: Obesity Toolkit for Primary Care ProvidersParticipants 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Health Literacy and Culturally Tailored Materials, Other: Primary Care Provider TrainingParticipants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Health Literacy and Culturally Tailored MaterialsParticipants will receive health literacy-appropriate written information on community resources and weight management | Behavioural | Enhanced Usual Care, LA-CEAL CONNECT Intervention |
| Community-Engaged Health Coaching and NavigationParticipants 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. | Behavioural | LA-CEAL CONNECT Intervention |
| Self-Monitoring and Remote Patient Monitoring of weight and physical activityParticipants 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. | Behavioural | LA-CEAL CONNECT Intervention |
| Community 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. | Other | LA-CEAL CONNECT Intervention |
| Primary Care Provider TrainingEducation 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. | Other | Enhanced Usual Care, LA-CEAL CONNECT Intervention |
| Obesity Toolkit for Primary Care ProvidersWe 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. | Other | LA-CEAL CONNECT Intervention |
Primary outcome
Between-group difference in % weight change
Time frame: 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.
5 secondary outcomes
Between-group difference in change in waist circumference
Time frame: 6 months
Between-group difference in change in blood pressure
Time frame: 6 months
Between-group difference in change in dietary intake
Time frame: 6 months
Between-group difference in change in physical activity
Time frame: 6 months
Between-group difference in change in quality of life
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
Marie Krousel-Wood, MD, MSPH principal investigator
Tulane University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Literacy and Culturally Tailored Materials, Community-Engaged Health Coaching and Navigation and Self-Monitoring and Remote Patient Monitoring of weight and physical activity in people with Obesity, run by Tulane University at 18 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 6 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Perry, PhD (504-988-8906, Lperry5@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in % weight change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.