Med-South Weight Loss Intervention for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weight Loss+2 MoreMed-South Weight Loss Intervention - Behavioral
Eligibility
18 - 75
All Sexes
What conditions do you have?
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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

1 of 3

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

1 of 3

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: Behavioral
Augmented Usual Care (WW)
Behavioral
ActiveComparator Group · 1 Intervention: WW · Intervention Types: Behavioral

Trial 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