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Type 2 DiabetesNCT07883343

Effects of Adding a Registered Dietitian to Rural Community Healthy Behavior Support Services for Management of Type 2 Diabetes

A study testing Medical Nutrition Therapy Intervention in people with Type 2 Diabetes, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rural communities experience health care shortages of diabetes services provided by a registered dietitian nutritionist (RDN). This pilot study tested the feasibility of using rural community health screenings to recruit adults with Type 2 Diabetes (T2D) and provide Medical Nutrition Therapy (MNT), testing its impact… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Medical Nutrition Therapy Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
16 May 2023to 27 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old
  • Body mass index (BMI) ≥ 25 kg/m2
  • Type 2 diabetes diagnosis

Who cannot join

  • Type 1 diabetes
  • Gestational diabetes mellitus
  • Currently receiving medical nutrition therapy from a registered dietitian nutritionist

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University

    Bloomington, Indiana, 47405

Other trials in United States

About this study

Official title: Effect of Adding a Registered Dietitian to Rural Community Healthy Behavior Support Services for Management of Type 2 Diabetes

Rural communities experience health care shortages of diabetes services provided by a registered dietitian nutritionist (RDN). This pilot study tested the feasibility of using rural community health screenings to recruit adults with Type 2 Diabetes (T2D) and provide Medical Nutrition Therapy (MNT), testing its impact on health, diet, and physical activity. Recruitment, retention, and adherence rates measured feasibility. Health markers (BMI, non-fasted blood glucose and lipids) were collected at an initial and follow up (6-9 months) screening. Diet (24-hr) and physical activity (7-day) recalls were collected at the MNT visits (initial, 1 mo, 3 mo). Paired t-tests and linear mixed models assessed mean differences between timepoints. Based upon the results from this pilot study, future testing of the efficacy of this approach in a randomized controlled study may be warranted and may allow for expansion of diabetes services in rural Indiana.

Read the detailed description

Summary abstract: Rural communities experience health care shortages of diabetes services provided by a registered dietitian nutritionist (RDN). This pilot study tested the feasibility of using rural community health screenings to recruit adults with Type 2 Diabetes (T2D) and provide Medical Nutrition Therapy (MNT), testing its impact on health, diet, and physical activity. Recruitment, retention, and adherence rates measured feasibility. Health markers [body mass index (BMI), non-fasted blood glucose and lipids, blood pressure, waist circumference] were collected at an initial and follow up (6-9 months) screening. Diet (24-hr) and physical activity (7-day) recalls were collected at the MNT visits (initial, 1 month, 3 month). Paired t-tests and linear mixed models assessed mean differences between timepoints.

Introduction: In the U.S., approximately 38.1 million adults aged 18 years or older have diabetes which is a prevalence rate of 14.7% based on 2021 estimates. Of these cases, 90% to 95% are type 2 diabetes (T2D). The estimated prevalence of diabetes in Indiana is 12.1% based on 2021 estimates.

Individuals with T2D are highly susceptible to major complications such as heart disease, stroke, renal failure, blindness, and amputations. The total estimated cost attributable to diabetes and its complications in the U.S. in 2022 is $412.9 billion. There are significant geographic disparities in diabetes prevalence between rural and urban areas. Prevalence of diabetes has been reported from 9% to 17% higher in rural areas than in urban areas. Diabetes has been identified as one of the top 10 Healthy People 2030 priorities for the rural United States. Rural communities experience health care shortages of not only primary care doctors for diabetes but also services provided by a registered dietitian nutritionist (RDN) such as medical nutrition therapy (MNT) and diabetes education. While RDs have been incorporated in team-based care in primary care clinics, team-based care models and support services (including a RDN) in rural communities are not typically present. This pilot study focused on Indiana rural communities experiencing health care shortages of diabetes service. The study's objectives were to test: (1) the feasibility of using rural community health screening events to recruit participants with T2D, (2) the feasibility of implementing MNT virtually by a RDN for 3 months, (3) the impact of the MNT on health markers of diabetes management, dietary intake and physical activity.

Methods:

Study population: Participants in SIHHH with T2D living in Southern Indiana counties (Crawford, Daviess, Dubois, Greene, Jackson, Lawrence, Martin, Orange, and Washington) were referred by nurses (RN) to the RDN as part of healthy behavior support services. The goal was to recruit 20 adults ≥ 18 years old with body mass index (BMI) ≥ 25 kg/m2 and a T2D diagnosis.

The enrollment of 20 participants was meant to allow the researchers to pilot test the feasibility of MNT delivered virtually by a RDN for 3 months, by assessing metrics regarding recruitment, enrollment and retention as well as the impact on changes in BMI and hemoglobin A1c (HbA1c) from the initial health screening to the follow up health screening. This data was intended to evaluate delivery of the intervention, as well as to obtain data on changes in biometrics for power calculations for a future randomized controlled trial.

Outcome measures: Feasibility outcomes included the number of health events and health screens, recruitment, retention, and adherence to MNT. Behavior outcomes included dietary intake and physical activity. Health outcomes included BMI, HbA1c, non-fasting blood glucose and lipids (total, HDL, and LDL cholesterol, triglycerides), blood pressure, and waist circumference.

Intervention: The SIHHH program provided RN led health screenings at public health centers/clinics, within health ministry centers/offices, mobile units, and health fairs. Health screenings included collection of demographics, weight, height, blood glucose, blood lipids, blood pressure, and waist circumference. HbA1c was calculated using blood glucose [Average HbA1c = (46.7 + non fasting glucose)/28.7]. RNs identified participants who met eligibility criteria of the pilot study and provided information about the MNT service. Individuals who expressed interest signed a consent form to receive the MNT, agreed to researchers' access to their electronic records as part of SIHHH, and agreed to provide information on their diet and physical activity habits. Participants were provided a packet of resources including Healthy Eating and Being Active from the Association of Diabetes Care \& Education Specialists, Meal Planning and Carb Counting from Novo Care of Novo Nordisk, and Healthy and Balanced Eating with MyPlate from United States Department of Agriculture. Participants were also provided a set of food measuring utensils and a My Plate food plate to assist with portion size. As part of the SIHHH Program, follow up health screenings occurred at 6-8 months post the initial screening. This data was evaluated to understand if there is any sustained impact of the MNT.

The MNT intervention was delivered virtually for three months by the RDN, who was also a Certified Diabetes Educator (CDE). During the initial MNT visit, the RDN used motivational interviewing techniques to identify the participant's interests and motivation for diabetes management. Participants set one goal on nutrition/healthy eating and one goal on physical activity. Based on the goals, the RDN provided diabetes education on blood glucose targets, use of blood glucose monitor, menu planning, or carbohydrate counting; eventually all of these topics were included in the subsequent MNT visits. To obtain data on dietary intake and physical activity, respectively, the RDN administered a 24-hr dietary recall and a 7-day physical activity recall (International Physical Activity). The 24-hour dietary recall included details about food/beverage intake, food preparation, and meal timing. The 7-day physical activity recall included details on types and intensity of activities as hours per day and number of days with at least 10 minutes of the activity. The RDN also administered these recalls during the 1- and 3-month visits encouraging health behavior changes to improve blood glucose levels. The RDN continued to address meal planning, carbohydrate counting, portion size, macronutrients, eating out, and physical activity during the 1- and 3-month visits. The RDN continued to use motivational interviewing techniques to assess progress and determine areas for improvement. The MNT intervention ended after the 3-month visit. Repeated measures of the biometric data were collected at the health screening which occurred at 6-8 months post the initial screening.

Data Analysis: Feasibility outcomes including the number of health events and screenings, recruitment, and retention were recorded. Adherence to the intervention was measured by recording attendance at the MNT visits. Dietary intake and physical activity data collected at the initial, 1- and 3-month MNT visits were analyzed using linear mixed models to evaluate changes overtime. The dietary data was assessed using the Nutrition Data System for Research (NDSR, University of Minnesota) for calories, macronutrients and micronutrients and change from initial visit to the 1- and 3- month MNT visits were analyzed. Change from initial visit to the 1- and 3-month MNT visits for hours per day and days of at least 10 minutes of physical activity were analyzed. Health outcomes including BMI, HbA1c, blood glucose, lipids, and blood pressure obtained from the SIHHH initial health screening (prior to MNT) and at the SIHHH follow up health screening (6-8 months) were used to determine changes overtime. Statistical differences from the initial screening to the follow up screening were determined using paired t-tests.

Conditions
Type 2 Diabetes
Being tested
Medical Nutrition Therapy Intervention
Keywords
Medical Nutrition Therapy, Telehealth, Type 2 Diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical Nutrition Therapy InterventionBehavioural

    In this single arm pilot study, telehealth delivered medical nutrition therapy (MNT) was provided by a registered dietitian nutritionist (RDN) to individuals with type 2 diabetes (T2D).

Study groups in NCT07883343
Study groupRoleWhat they receive
Medical Nutrition Therapy InterventionExperimentalIn this single arm pilot study, telehealth delivered medical nutrition therapy (MNT) was provided by a registered dietitian nutritionist (RDN) to participants who had type 2 diabetes (T2D).
Receives: Behavioral: Medical Nutrition Therapy Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility outcome: Community health events

    The number of community health events that occurred.

    Measured: From enrollment to end of study data collection at 8 months.

  2. Feasibility outcome: Health screenings at community health events

    The number of individual health screenings that were conducted at the community health events.

    Measured: From enrollment to end of study data collection at 8 months.

  3. Feasibility outcome: Recruitment Rate

    The percent of individuals identified with type 2 diabetes from the health screenings that were recruited to receive MNT.

    Measured: From enrollment to 6 months.

  4. Feasibility outcome: Retention rate

    The number of individuals who completed the MNT interventions and follow up health screen.

    Measured: From enrollment to end of study data collection at 8 months.

  5. Feasibility outcome: Adherence rate

    The participant rate of adherence to MNT.

    Measured: From enrollment to end of MNT provision at 3 months.

Secondary outcomes (10)
  1. Behavior outcome: Dietary intake

    Dietary intake was collected using a 24 hour recall.

    Measured: From enrollment to end of MNT at 3 months.

  2. Behavior outcome: Physical Activity

    Physical activity was collected using a 7-day record.

    Measured: From enrollment to end of MNT at 3 months.

  3. Health outcome: Height

    Height was self reported in inches.

    Measured: From enrollment to end of study data collection at 8 months.

  4. Health outcome: Weight

    Body weight (lbs) was measured using digital scale.

    Measured: From enrollment to end of study data collection at 8 months.

  5. Health outcome: Blood glucose

    Non fasting blood glucose (mg/dL) was measured by point of care instrument.

    Measured: From enrollment to end of study data collection at 8 months.

  6. Health outcome: HbA1c

    HbA1c (%) was calculated using non-fasting blood glucose.

    Measured: From enrollment to end of study data collection at 8 months.

  7. Health outcome: Blood lipids

    Non fasting total, HDL, LDL cholesterol, triglycerides were measured by point of care instrument (mg/dL).

    Measured: From enrollment to end of study data collection at 8 months.

  8. Health outcome: Blood pressure

    Blood pressure was measured by digital sphygmomanometer.

    Measured: From enrollment to end of study data collection at 8 months.

  9. Health outcome: Waist circumference

    Waist circumference (in) was assessed with tape measure.

    Measured: From enrollment to end of study data collection at 8 months.

  10. Health outcome: BMI

    BMI was calculated from height and weight.

    Measured: From enrollment to end of study data collection at 8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start16 May 2023
  3. Primary completion27 Jun 2024
  4. Study completion27 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07883343
Sponsor's protocol ID
17909
Other IDs
2280860-IUBRD
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD does not need to be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Medical Nutrition Therapy Intervention in people with Type 2 Diabetes, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility outcome: Community health events (time frame: From enrollment to end of study data collection at 8 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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