Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 19, 2021

Primary Completion Date

June 3, 2022

Study Completion Date

June 3, 2022

Conditions
Insulin ResistanceObesityDiabetesHypertensionDyslipidemiasMetabolic Syndrome
Interventions
BEHAVIORAL

Diet Counseling

"Delivery of nutrition counseling intervention to improve diet quality. Suggested energy intake will be prescribed with the intent to maintain energy balance and current body weight. A total of 16 nutrition counseling sessions lasting \~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). Responding participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of nutrition counseling through the end of the study, meeting with the dietitian every other week. Starting at week 9, those identified as non-responding participants will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin."

BEHAVIORAL

Exercise Counseling

"Delivery of exercise counseling intervention to increase engagement in physical activity. The exercise specialist will counsel participants to progressively increase their weekly physical activity. Weight loss is not a primary goal of these exercise counseling sessions. A total of 16 exercise counseling sessions lasting \~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). Responding participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of exercise counseling through the end of the study, meeting with the exercise specialist every other week. Starting at week 9, those identified as non-responders will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin."

Trial Locations (1)

35205

UAB Highlands Family and Community Medicine Clinic, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER