Study Summary
This trial will compare a new weight-loss program, developed to be more acceptable and realistic for southerners, with WW™ (formally Weight Watchers). Those who take part will be randomly assigned to one of the two programs. The primary outcome measured by the trial will be weight loss at 24 months, but researchers will also collect data which may show additional health benefits of the Med-South diet.
Eligible Conditions
- Weight Loss
- Healthy Eating
- Cardiovascular Risk
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 24 Secondary · Reporting Duration: Baseline, Month 4, 12, and 24
Baseline, Month 24
Mean Weight Change from Baseline to Month 24
Month 4
Mean Change LDL-cholesterol from Baseline through Follow-up
Mean Change in A1c from Baseline through Follow-Up
Mean Change in Alternate Healthy Eating Index (AHEI)-2010 from Baseline through Follow-Up
Mean Change in CRP from Baseline through Follow-Up
Mean Change in Diet Self-Efficacy from Baseline through Follow-Up
Mean Change in Dietary Self-Regulation from Baseline through Follow-Up
Mean Change in Eating Attitudes from Baseline through Follow-Up
Mean Change in Global Physical Activity Questionnaire (GPAQ) from Baseline through Follow-Up
Cholesterol
Mean Change in IL-6 from Baseline through Follow-Up
Mean Change in Quality of Life Scale from Baseline through Follow-Up
Mean Change in Self-Weighing Behaviors from Baseline through Follow-Up
Mean Change in Skin Carotenoids from Baseline through Follow-Up
Mean Change in TNF-alpha from Baseline through Follow-Up
Mean Change in Total Cholesterol from Baseline through Follow-Up
Mean Change in Triglycerides from Baseline through Follow-Up
Weight decreased
Month 4
Mean Weight Change from Baseline to Months 4 and 12
Month 4
Mean Change in Diastolic Blood Pressure from Baseline through Follow-Up
Mean Change in Systolic Blood Pressure from Baseline through Follow-Up
Mean Weight Change from Baseline through Follow-Up by Sub-Groups
Percentage Weight from Baseline through Follow-Up
Month 24
Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained
Economic Outcome--Incremental Cost-Effectiveness
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Augmented Usual Care (WW)
1 of 2
Med-South Weight Loss Intervention
1 of 2
Active Control
Experimental Treatment
360 Total Participants · 2 Treatment Groups
Primary Treatment: Med-South Weight Loss Intervention · No Placebo Group · N/A
Med-South Weight Loss Intervention
Behavioral
Experimental Group · 1 Intervention: Med-South Weight Loss Intervention · Intervention Types: BehavioralAugmented Usual Care (WW)
Behavioral
ActiveComparator Group · 1 Intervention: WW · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 4, 12, and 24
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,372 Previous Clinical Trials
3,930,884 Total Patients Enrolled
19 Trials studying Weight Loss
4,139 Patients Enrolled for Weight Loss
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,599 Previous Clinical Trials
46,956,140 Total Patients Enrolled
33 Trials studying Weight Loss
7,016 Patients Enrolled for Weight Loss
Carmen D Samuel-Hodge, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Thomas C Keyserling, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Eligibility Criteria
Age 18 - 75 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have access to a telephone.\n
You must have received approval from a primary care clinician for participation in the study.
References
- Samuel-Hodge, Carmen D., Beverly A. Garcia, Larry F. Johnston, Ziya Gizlice, Andy Ni, Jianwen Cai, Jennifer L. Kraschnewski, et al.. 2013. “Translation of a Behavioral Weight Loss Intervention for Mid-life, Low-income Women in Local Health Departments”. Obesity. Wiley. doi:10.1002/oby.20317.
- Samuel-Hodge, Carmen D., Judith C. Holder-Cooper, Ziya Gizlice, Gwendolyn Davis, Sonia P. Steele, Thomas C. Keyserling, Shiriki K. Kumanyika, Phillip J. Brantley, and Laura P. Svetkey. 2016. “Family Partners in Lifestyle Support (PALS): Family-based Weight Loss for African American Adults with Type 2 Diabetes”. Obesity. Wiley. doi:10.1002/oby.21700.
- Samuel-Hodge, Carmen D., Larry F. Johnston, Ziya Gizlice, Beverly A. Garcia, Sara C. Lindsley, Kathy P. Bramble, Trisha E. Hardy, et al.. 2009. “Randomized Trial of a Behavioral Weight Loss Intervention for Low-income Women: The Weight Wise Program”. Obesity. Wiley. doi:10.1038/oby.2009.128.
- Keyserling, Thomas C., Carmen D. Samuel-Hodge, Stephanie Jilcott Pitts, Beverly A. Garcia, Larry F. Johnston, Ziya Gizlice, Cassandra L. Miller, et al.. 2016. “A Community-based Lifestyle and Weight Loss Intervention Promoting a Mediterranean-style Diet Pattern Evaluated in the Stroke Belt of North Carolina: The Heart Healthy Lenoir Project”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-016-3370-9.
- Keyserling, Thomas C., Carmen D. Samuel Hodge, Stephanie B. Jilcott, Larry F. Johnston, Beverly A. Garcia, Ziya Gizlice, Myron D. Gross, et al.. 2008. “Randomized Trial of a Clinic-based, Community-supported, Lifestyle Intervention to Improve Physical Activity and Diet: The North Carolina Enhanced WISEWOMAN Project”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2008.02.011.
- Keyserling, Thomas C., Stacey L. Sheridan, Lindy B. Draeger, Eric A. Finkelstein, Ziya Gizlice, Eliza Kruger, Larry F. Johnston, et al.. 2014. “A Comparison of Live Counseling with a Web-based Lifestyle and Medication Intervention to Reduce Coronary Heart Disease Risk”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2014.1984.
- Embree, Genevieve G R, Carmen D Samuel-Hodge, Larry F Johnston, Beverly A Garcia, Ziya Gizlice, Kelly R Evenson, Darren A DeWalt, Alice S Ammerman, and Thomas C Keyserling. 2017. “Successful Long-term Weight Loss Among Participants with Diabetes Receiving an Intervention Promoting an Adapted Mediterranean-style Dietary Pattern: The Heart Healthy Lenoir Project”. BMJ Open Diabetes Research & Care. BMJ. doi:10.1136/bmjdrc-2016-000339.
- Keyserling, Thomas C., Carmen D. Samuel Hodge, Stephanie B. Jilcott, Larry F. Johnston, Beverly A. Garcia, Ziya Gizlice, Myron D. Gross, et al.. 2008. “Randomized Trial of a Clinic-based, Community-supported, Lifestyle Intervention to Improve Physical Activity and Diet: The North Carolina Enhanced WISEWOMAN Project”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2008.02.011.
- Embree, Genevieve G R, Carmen D Samuel-Hodge, Larry F Johnston, Beverly A Garcia, Ziya Gizlice, Kelly R Evenson, Darren A DeWalt, Alice S Ammerman, and Thomas C Keyserling. 2017. “Successful Long-term Weight Loss Among Participants with Diabetes Receiving an Intervention Promoting an Adapted Mediterranean-style Dietary Pattern: The Heart Healthy Lenoir Project”. BMJ Open Diabetes Research & Care. BMJ. doi:10.1136/bmjdrc-2016-000339.
- Samuel-Hodge, Carmen D., Larry F. Johnston, Ziya Gizlice, Beverly A. Garcia, Sara C. Lindsley, Kathy P. Bramble, Trisha E. Hardy, et al.. 2009. “Randomized Trial of a Behavioral Weight Loss Intervention for Low-income Women: The Weight Wise Program”. Obesity. Wiley. doi:10.1038/oby.2009.128.
- Keyserling, Thomas C., Stacey L. Sheridan, Lindy B. Draeger, Eric A. Finkelstein, Ziya Gizlice, Eliza Kruger, Larry F. Johnston, et al.. 2014. “A Comparison of Live Counseling with a Web-based Lifestyle and Medication Intervention to Reduce Coronary Heart Disease Risk”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2014.1984.
- Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med. 2008 Jun;46(6):499-510. doi: 10.1016/j.ypmed.2008.02.011. Epub 2008 Feb 15.
- 2020. "Delicious Eating for Life in Southern Homes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04302727.
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