Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers

NCT03781102 | Terminated

• 1 other identifier: 1R34DK118486-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The two main questions that this research study will answer:

1. 1.will a 16-week community-based diabetes prevention program for delivery to at-risk mothers and children in a Federally Qualified Health Center (FQHC) setting show (a) pre- and post-intervention improvements to Type 2 Diabetes risk factors in 60 mother-child dyads; (b) intervention vs. control improvements to T2D risk factors in 30 mother-child dyads; and (c) maintenance effects to changes to Type 2 Diabetes risk factors in 30 mother-child dyads; and
2. 2.based on the acceptability, adoption, relevance to FQHC and participants, feasibility, fidelity, program costs, and factors influencing sustainability of this program, can it be disseminated nationwide to other FQHC's?

Conditions

PreDiabetes; Type 2 Diabetes

Keywords

Type 2 Diabetes; Diabetes Prevention; Prediabetes Intervention; Mothers; Children; Federally Qualified Health Center (FQHC) Program

Outcome Measures

Primary Outcomes (4)

• Change in Body Weight

  Body weight (kg) is measured using a calibrated, Cardinal Detecto ProDoc Series PD300MHR Digital Physician scale and a Cardinal Detecto 758C Weight Indicator

  Baseline, Week 16, Week 32

• Change in Body Height

  Body height (cm) measured using a calibrated, Cardinal Detecto ProDoc Series PD300MHR Digital Physician scale with a mechanical height rod and a Cardinal Detecto 758C Weight Indicator with a Seca 213 Portable Stadiometer.

  Baseline, Week 16, Week 32

• Change in Body Mass Index (BMI)

  BMI (kg/m2) is categorized using international classifications of BMI (overweight, 25-29.9kg/m2; obese, \>30kg/m2) (WHO 2006).

  Baseline, Week 16, Week 32

• Change in Body Mass Index (BMI) Percentile

  BMI percentile in children is determined using age- and sex-specific growth charts developed by the CDC in 2000 (Kuczmarski 2000).

  Baseline, Week 16, Week 32

Secondary Outcomes (9)

• Change in Waist Circumference

  Baseline, Week 16, Week 32

• Change in Blood Pressure

  Baseline, Week 16, Week 32

• Change in HbA1C

  Baseline, Week 16, Week 32

• Change in Total Cholesterol / HDL-cholesterol

  Baseline, Week 16, Week 32

• Change in Dietary Intake (daily eating patterns)

  Baseline, Week 16, Week 32

Study Arms (2)

Intervention

EXPERIMENTAL

Arm 1, or intervention participants (n=60), will participate in a 16-week face-to-face diabetes prevention group program '16-Week Diabetes Prevention Program for Mothers and Children' and then will transition to a 16-week follow-up period.

Behavioral: 16-Week Diabetes Prevention Program for Mothers and Children

Wait-listed Control

OTHER

Arm 2, or wait-listed controls (n=60), will receive the typical standard of care during the first 16-weeks, followed by the 16-week face-to-face group diabetes prevention program '16-Week Diabetes Prevention Program for Mothers and Children'.

Behavioral: 16-Week Diabetes Prevention Program for Mothers and Children

Interventions

16-Week Diabetes Prevention Program for Mothers and Children BEHAVIORAL

The 16-week intervention is focused on ways to modify behaviors associated with the pathogenesis of Type 2 Diabetes in youth, while engaging participants in fun, active, and interactive food demonstrations, energy balance, and physical activities appropriate for all the family. Weekly sessions will consist of: (1) physical activity upon arrival; (2) small group discussions; (3) hands-on food preparation and tasting opportunities; (4) low- to no-cost fun family physical activities; (5) energy balance activities (e.g. label reading) to increase foundational knowledge; and, (6) opportunities to set new weekly goals.

Intervention; Wait-listed Control

Eligibility Criteria

• Age: 8 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Child:
• years-old (if the mother has more than one child in the age range, the oldest child will be invited to participate; other children will be invited to join if the mother wishes it, but will not be measured),
• overweight/obese (≥85th percentile of BMI for age and sex, and ≥2 of the following T2D risk factors: family history of T2D in first or second degree relative; or, identify as a racial/ethnic minority; or, exhibit signs of insulin resistance or conditions associated with insulin resistance, or mother with T2D or GDM during gestation.
• Able to read and speak English, and provide written assent.
• Mother:
• years-old,
• BMI ≥ 25 kg/m2 and a risk score ≥5 on the seven-item American Diabetes Association's Diabetes Risk Assessment (84). In addition, women must have prediabetes, determined by an HbA1c value \>5.7% and \<6.5%, or, a self-reported or chart documented history of gestational diabetes mellitus with an HbA1c \<6.5% and/or casual capillary blood glucose \<199 mg/dL.
• Must be willing to participate with their child in all intervention activities and sessions,
• Able to read and speak English or Spanish, and provide informed consent.

You may not qualify if:

• Mother:
• No evidence of prediabetes
• Currently pregnant or planning to become pregnant during the study
• Have any condition or use any medication that could alter glucose metabolism or weight
• Have suffered a heart attack, stroke or transient ischemic attack (TIA) in the past 6 months
• Have uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg)
• Received treatment for cancer (excluding surgery alone) within the last 2 years (excluding skin cancer)
• Report chest pain, shortness of breath with minimal activity or at rest or unexplained dizziness or fainting with physical activity,
• Have chronic lung disease, chronic obstructive pulmonary disease, or asthma requiring home oxygen therapy,
• Current use of anti-diabetes medications for the treatment of diagnosed diabetes, are unable to communicate with research staff (including intervention staff),
• Do not have a child within the designated age range (8-12-years-old),
• Unable to speak or read English or Spanish.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

El Rio Community Health Center

Tucson, Arizona, 85701, United States

Location

Related Publications (15)

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  PMID: 20957426 BACKGROUND

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  PMID: 24830053 BACKGROUND

• Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.

  PMID: 18055651 BACKGROUND

• Centers for Disease Control and Prevention. National Diabetes Prevention Program 2017. Available at: https://www.cdc.gov/diabetes/prevention/index.html [Accessed on October 18, 2017]

  BACKGROUND

• Albright AL, Gregg EW. Preventing type 2 diabetes in communities across the U.S.: the National Diabetes Prevention Program. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S346-51. doi: 10.1016/j.amepre.2012.12.009.

  PMID: 23498297 BACKGROUND

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  PMID: 17605557 BACKGROUND

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  PMID: 26679186 BACKGROUND

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  PMID: 24604714 BACKGROUND

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  PMID: 22594758 BACKGROUND

• World Health Organization (WHO). BMI classification. 2006 Available at: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html [Accessed on October 18, 2017]

  BACKGROUND

• Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.

  PMID: 11183293 BACKGROUND

• Marrero DG, Blew RM, Palmer KNB, James K, Roe DJ, Hingle MD. Rationale and design of a type 2 diabetes prevention intervention for at-risk mothers and children at a Federally Qualified Healthcare Center: EPIC El Rio Families Study Protocol. BMC Public Health. 2021 Feb 12;21(1):346. doi: 10.1186/s12889-021-10392-w.

  PMID: 33579240 DERIVED

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Melanie D Hingle, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• David G Marrero, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Nutritional Sciences

Model Details: Participants (60 children and their biological mothers (n=120)) will be assigned to a clinic location nearest to their home address, which will determine the order in which they will complete the 16-week intervention. Two clinics were selected to participate in this pilot study. Randomization to the intervention and wait-list control conditions will be performed \*by site\* (flip of a coin). Randomization by site is proposed as it has the least potential for contamination during the initial delivery period. Group A participants (n=30) will begin the 16-week face-to-face group program immediately, whereas the Group B participants (n=30) will receive normal standard of care. After 16 weeks, the Group A participants will transition to follow-up while the Group B participants begin the intervention. This design is responsive to standards of care for T2D prevention by primary care providers and will provide the opportunity to investigate all the outcome questions.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: July 1, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)