Clinical trial NCT04533659: Personalized Behavioral Nutrition Intervention in Older AAs With T2D
Official title: Personalized Behavioral Nutrition Intervention in Older Asian Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Personalized behavioral nutrition
Pilot study
Hybrid randomized clinical trial
Older Asian Americans
Metabolomics approach
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The Rutgers Asian Resource Center for Minority Aging Research (RCMAR)
First posted: 2020-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The rapid growth rate and unique challenges as a new immigrant group call for a better understanding of the social and health needs of the older Asian Americans (AAs) population. Overwhelming numbers of AAs, a fast-growing first-generation immigrant group, suffer from type 2 diabetes (T2D) and its consequences of poorly controlled blood glucose. For the older AAs, there are higher prevalence rates, worse diabetes control, and higher rates of complications due to limited English proficiency and health literacy. Despite the evidence concerning the effects of dietary interventions on glycemic control by well-controlled feeding studies in mainstream Americans, a lack of clinical trials of culturally tailored interventions often imposes serious barriers to translate and implement such fruitful and innovative approaches in individuals from ethnic minority communities such as AAs.

The proposed study will use a randomized, controlled design with a sample of 60 AAs aged 65 years or older. Metabolomics methodologies will be incorporated into this research to provide a global picture of metabolites' responses to personalized behavioral nutrition (PBN) intervention. The study results will obtain the necessary information to conduct a meaningful community-based clinical trial to test the effectiveness of PBN in improving dietary patterns and glycemic control in older AAs.

Detailed description: This study is designed with two aims:

1. to determine if PBN intervention improves glycemic control, weight control, and metabolites profiles compared with the control group.
2. to identify significant factors that influence the relative effectiveness of PBN and the relative acceptability of PBN.

Eligibility criteria: Inclusion Criteria:

1. Self-identified as Asian Americans (Chinese, Korean, or South Asian)
2. Age 65 years or older
3. Residing in the Bexar County area
4. Diagnosed with type 2 diabetes; A1C ≥7.5% within 6 months of screening
5. Expressing a willingness to participate in all aspects of the study over its full course
6. Possession of a smartphone

Exclusion Criteria:

1. Unable to give informed consent
2. People under another diet regime that is different from the ADA recommended diet
3. Physical or mental health conditions that could limit active participation in the study (e.g., severe illness, blindness in both eyes, severe immobility, psychiatric diseases)
4. Hematological condition that would affect A1C assay, e.g., hemolytic anemia, sickle cell anemia

Primary outcomes:
measure: Glycemic control
timeFrame: Baseline, 4-week, 8-week
Secondary outcomes:
measure: Metabolites profiles
timeFrame: Baseline, 4-week
measure: Lipids profiles
timeFrame: Baseline, 4-week, 8-week
measure: Weight
timeFrame: Baseline, 4-week, 8-week
measure: Dietary intake
timeFrame: Over the 4-week
measure: Physical activity
timeFrame: Over the 4-week
measure: In-home self-monitoring of blood glucose
timeFrame: Over the 4-week
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Jisook Ko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ko J, Wang J, Du Y, Jiwani R, Li C. Personalized Behavioral Nutrition Among Older Asian Americans: Study Protocol. Nurs Res. 2021 Jul-Aug 01;70(4):317-322. doi: 10.1097/NNR.0000000000000514.