Healthy Living Anson Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The goal of this randomized delayed control intervention research study is to see if participants who receive education and healthy prepared meals improve the quality of their diet compared to participants who receive only physical activity education and coaching.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Potential participants must be a resident of Anson County.
At least 18 years of age.
Have or be at risk for a chronic disease.
Ability to make own dietary decisions.
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Nutrition Education and Food Delivery
BehavioralHealthy frozen meals, produce boxes, and nutrition counseling
Physical Activity Comparator
BehavioralPhysical activity counseling, mHealth text messaging
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Nutrition Education and Food Delivery, Then Physical Activity ComparatorExperimental treatment 2 interventions
Group B: Physical Activity Comparator, Then Nutrition Education and Food DeliveryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Med-South Dietary Risk Assessment Score
The Med-South Dietary Risk Assessment (DRA) is scored as the sum of the column score for each numbered item, with column score multiplied by 0.5 for Items 3.3 and 3.4. The score ranges from 0 to 10, 0 meaning no adherence and 10 meaning full adherence. With regard to diet quality, the first response option is considered "desirable," the second "could be improved," and the third "needs to be improved.
Time frame
Baseline, Midpoint (Month 4), Endpoint (up to Month 10)Secondary outcomes
1
Physical Activity Questionnaire
Assessed by the International Physical Activity Questionnaire (IPAQ) - Short Form. This questionnaire is a well-validated 7-day physical activity recall assessment for physical activity. This will measure frequency (days per week) and duration (time per day) for each specific type of activity. Three specific activity types will be scored, walking, moderate-intensity activity, and vigorous-intensity activity. Participants will be scored based on metabolic equivalent of task units (MET, energy expenditure). This will be determined by multiplying the frequency by duration (in hours). Each activity type will have MET calculated separately, and the summation of each score will generate the the overall physical activity score in MET units. Scores will range from 0-99. We will only report the overall score. Higher scores indicate higher levels of physical activity and more energy expenditure.
Time frame
Baseline, Midpoint (Month 4), Endpoint (Up to Month 10)2
Skin Carotenoids
Description: Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. A Veggie Meter uses reflection spectroscopy to determine the level of skin carotenoids using the fingertip. Measurements are taken three times, with scores being averaged and reported. A higher score indicates more fruit and vegetable intake.
Time frame
Baseline, Midpoint (month 4), Endpoint (up to month 10)3
Nutrition Insecurity
Nutrition Insecurity will be measured using a survey with one item. This item indicates the frequency in which a participant has skipped or cut the size of meals due to lack of finances. Frequency is established using a likert scale, always to never, with one selection option. Always would signify high nutrition insecurity, and never would signify low nutrition insecurity.
Time frame
baseline, endpointSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Westat
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov