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Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients

7 juni 2019 bijgewerkt door: University of Nebraska Lincoln
In this project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management among adults with type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management activities, and awareness of cardiovascular diseases. We collected also collect patient's self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

Type 2 diabetes and its complications have become an important public health problem, affecting nearly 350 million adults worldwide. However, successfully managing type 2 diabetes through proper nutrition and healthy lifestyles remains challenging for many diabetes patients. In this proposed project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management, and quality of life among adults with type 2 diabetes among adults with Type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). Inclusion criteria for the study sample of adult type II diabetes patients were: adults ages 30 or older, English speaking, and Hemoglobin A1C levels > 6.5%.

Adult type 2 diabetes patients were recruited from the Center for Diabetes & Nutritional Health, an outpatient diabetes clinic of Methodist Hospital in Omaha with the assistance of Certified Diabetes Educators and Registered Dietitians. Diagnosis of type 2 diabetes were based on patient self-report and verified by the Co-Primary Investigator (who is Certified Diabetes educator and registered dietitian at the Methodist Hospital. The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. Text messages were sent by the project investigators to the participants in the intervention group via a free computer-based text messaging service. The computer was password protected and can only be accessed by the investigators. Participant's phone numbers used for text message intervention were kept private. Only investigators and research assistant know the participant's cell phone numbers used for text message intervention and each participant's cell number was not shared with anyone else including other study participants. Text messages were sent by the project investigators or research assistant to the patients and were one-way text messages, meaning that patient did not need to reply to the text messages. If a patient had a medical concern about his/her diabetes, he/she was advised not to send a text message to the investigator, but to contact his/her physician or call 911 instead. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management, awareness of cardiovascular diseases and home food environment. The investigators also collected patient's self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

79

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Nebraska
      • Lincoln, Nebraska, Verenigde Staten, 68583-0806
        • University of Nebraska-Lincoln (with Methodist Hospital System)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Self-report adult type 2 diabetes patients
  • Adults ages 30 or older
  • English speaking
  • Self-report Hemoglobin A1C > 6.5%
  • Have a cell phone able to receive text messages

Exclusion Criteria:

  • Individuals without Type 2 diabetes
  • Less than 30 years of age
  • Self-report Hemoglobin A1C less than 6.5%
  • Does not have a cell phone to receive text messages
  • Individuals who don't speak and understand English

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Text messaging
Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).
The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group will not receive text messages
Geen tussenkomst: Control
Participants will not receive text message intervention. This is the measurement-only group

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-Care Activities: Healthy Eating
Tijdsspanne: Three months
An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)
Three months
Diabetes Self-care Activity: Exercise
Tijdsspanne: Three months
Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)
Three months
Self-care Activity: Blood Glucose Testing
Tijdsspanne: three months
Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)
three months
Self-care Activity: Medication Adherence
Tijdsspanne: three months
Self-report survey question (days over the last seven days)
three months
Self-care Activity: Foot Care
Tijdsspanne: three months
Average of four self-report survey questions of the category (days over the last seven days)
three months
Eat >= 5 Servings Fruit and Vegetables
Tijdsspanne: Three months
Self report survey question (days/week)
Three months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-report Hemoglobin A1C
Tijdsspanne: Three months
Self-report hemoglobin for diabetes status
Three months
Frequency of Concern of CVD Event
Tijdsspanne: Three months
Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event
Three months
Total Carbohydrate
Tijdsspanne: One month
A self-report food frequency questionnaire over the past month
One month
Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity
Tijdsspanne: Three months
A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity
Three months
Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years
Tijdsspanne: Three months
Self report survey question
Three months
Degree of Concern of CVD Event in Lifetime
Tijdsspanne: Three months
Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime
Three months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Weiwen Chai, PhD, University of Nebraska Lincoln

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 februari 2017

Primaire voltooiing (Werkelijk)

31 mei 2018

Studie voltooiing (Werkelijk)

31 mei 2018

Studieregistratiedata

Eerst ingediend

24 januari 2017

Eerst ingediend dat voldeed aan de QC-criteria

30 januari 2017

Eerst geplaatst (Schatting)

1 februari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

7 juni 2019

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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