Brown University
Providence, Rhode Island, 02912, United States
NCT Number: NCT05817838
This small scale healthy eating study provides Southeast Asian families with children ages 6 to 11 with a family-based nutrition education, one-on-one interviews to help with motivation to eat health, text messaging, and coupons to purchase health foods and beverages. Since this is a small scale study that is a pilot intervention, the main goal of this intervention is to determine if it is feasible, meaning, can it be done. The second goal of this intervention is to determine if there are meaningful improvements in children's healthy eating patterns, body mass index and HbA1c. The third goal is to see if the intervention improves parent's diet quality, HbA1c and the home food environment. These study findings will be used to determine whether a larger clinical trial is needed, and if so, how it should be done.
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Notify Me6 year and older
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02912, United States
This intervention reflects the investigative team's eight year and ongoing academic-community research partnership with the Center for Southeast Asians (SEA) in Rhode Island, formative work with SEA families, and the team's extensive experience conducting successful dietary interventions. The current study is a pilot feasibility study that tests an innovative multilevel, multicomponent, multigenerational dietary intervention to improve diet quality among SEA children.
75 SEA families with children ages 6 to 11 years will be recruited from Providence County, Rhode Island. Adult-child pairs will be randomized to: (1) financial incentive only arm that will receive weekly $15 financial incentive coupons to subsidize purchase of healthy foods at a local SEA grocery store; or (2) financial incentive plus twice-monthly, family-based group nutrition education at the Center for SEA led by SEA community health workers; three motivational interviewing (MI) calls by trained community health workers; dietary norms messaging for adults (via weekly text messages) and for children (via Infographics at nutrition education sessions); and weekly $15 financial incentive coupons to subsidize purchase of healthy foods at SEA grocery stores; or (3) an Academic Engagement attention control arm that will follow the structure of the financial incentive plus nutrition education, MI and text messages and infographics arm. The primary outcomes are study feasibility and clinically meaningful improvement in child's diet quality (measured by healthy eating index). Secondary outcomes are clinically meaningful changes in children's body mass (~ 2kg weight loss or no weight gain), HbA1c (0.5%) and parent's diet quality, HbA1c and the home food environment. These study findings will be used to inform a future, larger clinical trial.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Adults:
Exclusion criteria
for Adults:
Inclusion criteria
for Children:
Exclusion criteria
for Children:
For six months, families will receive weekly, $15 financial incentives to purchase healthy foods and beverages at a partnering Southeast Asian grocery store
For six months, families will receive weekly, $15 financial incentives to purchase healthy foods and beverages at a partnering Southeast Asian grocer store, in-person, group-based nutrition education with other Southeast Asian families, text messages and motivational interviewing
For six months, families will attend in-person, group-based school engagement education with other Southeast Asian families designed to improve youths' academic outcomes. Families will receive text messages and motivational interviews. At the end of the six months, families will receive the equivalent of the six months worth of weekly, $15 financial incentives.
Time frame: Study enrollment to six-month follow-up
Feasibility will be demonstrated if 7 enrolled Southeast Asian families per month are recruited on average over 12 months
Time frame: Study enrollment to six-month follow-up
Feasibility will be demonstrated if 80% of enrolled families are retained at 6 months
Time frame: Study enrollment to six-month follow-up
Feasibility will be demonstrated if 0% of enrolled families attend in-person sessions
Time frame: Study enrollment to six-month follow-up
Acceptability for each intervention component will be achieved if at least 70% of participants rate the component as "favorable" or "very favorable" on the measure of acceptability
Time frame: Study enrollment to six-month follow-up
24-Hour dietary recall data will be converted to Healthy Eating Index scores to provide overall and subcomponent scores.
Time frame: Study enrollment to six-month follow-up
Children's fruit and vegetable intake will be determined using the Veggie Meter, which is an objective measure of dermal carotenoids over a two month period.
Time frame: Study enrollment to six-month follow-up
Objectively assessed height will be measured by research assistants using a portable stadiometer.
Time frame: Study enrollment to six-month follow-up
Objectively assessed weight will be measured by research assistants using the Tanita Body Weight Scale.
Time frame: Study enrollment to six-month follow-up
Weight and height measures will be combined to compute Body Mass Index. Body Mass Index will be determined using appropriate child and adult reference values, respectively.
Time frame: Study enrollment to six-month follow-up
Objectively assessed waist circumference will be measured by research assistants. Waist circumference categories will be determined using appropriate child and adult reference values, respectively.
Time frame: Study enrollment to six-month follow-up
Objectively assessed height, weight and waist circumference will be measured by research assistants. Body Mass Index and waist circumference categories will be determined using appropriate child and adult reference values, respectively.
Time frame: Study enrollment to six-month follow-up
Adult participants will complete a brief questionnaire to measure beverage intake (BEVQ-15).
Time frame: Study enrollment to six-month follow-up
Adult participants will complete the Townsend Food Behaviors Checklist regarding consumption of foods and healthy food-related behaviors.
Time frame: Study enrollment to six-month follow-up
A Veggie Meter score (objective measure of fruit and vegetable intake) will be obtained for adults.
Time frame: Study enrollment to six-month follow-up
Adults will complete a self-report survey of the home food environment using the 23-item Home Food Inventory checklist.
Time frame: Study enrollment to six-month follow-up
Child and adult HbA1c trained research staff will conduct finger sticks using established protocols (detailed protocol in Protection of Human Subjects)
Brown University
Other
Testing a Multilevel, Multicomponent, Multigenerational Dietary Intervention to Improve Southeast Asian Children's Diets
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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