Clinical trial NCT03781102: Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers
Official title: Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PreDiabetes
Type 2 Diabetes
Keywords: Type 2 Diabetes
Diabetes Prevention
Prediabetes Intervention
Mothers
Children
Federally Qualified Health Center (FQHC) Program
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 92
Sex: ALL
Minimum age (years): 8
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: The two main questions that this research study will answer:

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. 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?

The investigators hypothesize that participants (a) will show improvements following the intervention to T2D risk factors, (b) in the intervention will show significant improvements to T2D risk factors in versus the controls, and (c) will maintain the benefits beyond the 16-week intervention. The investigators also predict that this program will meet criteria to be disseminated nationwide to other FQHC's.

Detailed description: The goal is to implement and evaluate the effects of a 16-week behavioral lifestyle intervention on Type 2 Diabetes (T2D) risk factors delivered by trained staff at a Federally Qualified Health Center (FQHC) to 60 mothers with prediabetes or a history of gestational diabetes (GDM) and 60 overweight/obese children. The specific aims are to (1) adapt an efficacious community-based diabetes prevention program for delivery to FQHC patients, (2) evaluate indicators of program implementation and potential for dissemination (Proctor 2011), and (3) assess the preliminary impact of the program on participants' T2D risk factors.

The study aims to adapt an efficacious community-based diabetes prevention program developed for delivery to at-risk mothers and children at a FQHC. Successful T2D prevention in children necessitates family adoption of lifestyle behaviors associated with prevention of excess weight gain, while supporting normal growth and development. In accord with the 2012 Institute of Medicine Report (IOM 2012) and guidelines set forth by an Expert Committee (Barlow 2007), three healthy lifestyle goals form the basis for youth-focused aspects of the intervention: i) make physical activity an integral and routine part of life; ii) eat a healthy diet (both quality and quantity), and, iii) create food and physical activity environments to insure healthy options and behaviors are the routine, easy choice. These goals align with two evidence-based T2D prevention goals mothers will be encouraged to adopt: i) lose 7% of body weight through healthy eating, and ii) participate in at least 150 minutes of moderate-to-vigorous physical activity each week. Achievement of these goals has been associated with significant T2D risk reduction in participants of programs based on the Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (CDC 2017, Albright 2013). The intervention duration, content, and activities, designed to support families in meeting these recommendations, were drawn from the intervention literature (Wilfley 2010, Epstein 2007, Ackermann 2008, Hingle 2015). Intervention "dose" (duration × time) was modeled after the successful adult-focused DPP/YDPP (characterized by 16 core sessions) and the recently released 2017 U.S. Preventive Services Task Force (USPSTF) evidence-based recommendations for weight loss, behavior change, and cardio-metabolic risk reduction in youth (O'Connor 2017). The topics are focused on practical, culturally-relevant strategies for modifying the behaviors associated with the pathogenesis of T2D in youth (Spruijt-Metz 2014) (e.g., availability and accessibility of nutrient- and calorie-dense foods and food preparation strategies in the home, reducing intake of sugar-sweetened beverages, increasing time spent in physical activity/decreasing time spent in sedentary activities, stress management, and obtaining quality sleep), while engaging participants in fun, active, and interactive food demonstrations, energy balance, and physical activities appropriate for the entire family. All sessions are group-based (attended by up to 10 families total) and led by a minimum of two trained bilingual FQHC health and wellness staff. The sessions will be approximately 1.5-2 hours in length and conducted over 16 consecutive weeks at one of two FQHC locations. The sessions foster skill building and provide repeated opportunities to practice healthy lifestyle behaviors. Each session will follow a similar format consisting of: (1) a featured physical activity encouraging families to get moving upon arrival; (2) small group discussions focused on goal-setting and building intra- and inter-family camaraderie; (3) hands-on food preparation and tasting opportunities centered around vegetables, whole grains, and legumes; (4) low- to no-cost fun family physical activities (on alternating weeks, mothers will participate in a moderated discussion on proactive parenting); (5) energy balance activities (e.g. label reading) to increase foundational knowledge and skills related to healthy food selection, physical activity benefits, and creating a supportive home environment; and, (6) opportunities to set new weekly goals (or revise previous goals).

The second aim evaluates program implementation outcomes including acceptability, adoption, relevance to FQHC and participants, feasibility, fidelity, program costs, and factors influencing sustainability. Consistent with the tenets of implementation science (Glasgow 2012), these variables are assessed at recommended time points (Proctor 2011) to insure all aspects of the intervention work as intended, including participant acceptability (participant satisfaction) and relevance to FQHC personnel and study participants (rated using brief surveys of the relevance of the intervention to daily life, promoters and barriers to program attendance and engagement, the degree to which families report using the intervention to guide behavioral choices, and surveys of lifestyle coaches trained to deliver the intervention). The investigators also assess adoption by the FQHC and integration with the existing clinical setting (ascertained through semi-structured interviews with FQHC wellness staff and administrators exploring 'fit' among existing program offerings, availability of personnel and resources needed to implement, and potential for reimbursement) and feasibility (of delivery by providers and FQHC determined by recruitment, enrollment, and retention rates, adherence data including session attendance and observed participant engagement with intervention activities; a brief, three-question interview will be conducted with every eligible respondent who elects not to participate). Fidelity is assessed through observation of research staff following an established rubric, and program costs are evaluated using a bottom-up micro-costing approach (for participants, surveys assessing cost, burden, and benefit such as time and resources spent in travel, services, equipment, and food to meet program recommendations; FQHC direct medical and non-medical costs including personnel gross hourly salaries, intervention material costs, and overhead costs related to use of facilities for prevention services are tracked and analyzed in partnership with FQHC data team members). The investigators also explore the potential for replication and dissemination using semi-structured interviews with the FQHC wellness staff assigned to coordinate and deliver the program, and administrators and advisory board members who understand how to align the intervention with the FQHC's fiscal and strategic plans, and who have relationships with other FQHCs in Arizona and nationally. Program sustainability is also of great interest to the FQHC, thus our a priori focus on factors influencing sustainability (e.g., reach, integration with other health/wellness programs, institutionalization) beyond the research funding period are a major consideration throughout the proposed study. At the conclusion of the proposed work, this evaluation is designed to produce an intervention curriculum and approach suitable for replication and scaling across a larger number of (cluster-randomized) FQHC sites.

The third aim is to assess the preliminary efficacy of the program on T2D risk factors including weight status, metabolic syndrome phenotype, lifestyle behaviors, and socio-environmental determinants of health outcomes in 60 mothers and 60 children participating in the 16-week intervention. Intervention participants are measured at Week 0 (baseline), Week 16 (post-intervention), and Week 32 (maintenance) and wait-listed control participants at Week 0 (baseline), Week 16 (follow-up and pre-intervention), and Week 32 (post-intervention). Measurements are conducted by trained research staff following standardized measurement procedures, and take place at the FQHC site to which the child and parent is assigned. Care is taken to avoid simultaneous scheduling of intervention and wait-listed control families.

Eligibility criteria: Inclusion Criteria:

Child:

8-12-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:

18-54 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, Week 16, Week 32
measure: Change in Body Height
timeFrame: Baseline, Week 16, Week 32
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, Week 16, Week 32
measure: Change in Body Mass Index (BMI) Percentile
timeFrame: Baseline, Week 16, Week 32
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline, Week 16, Week 32
measure: Change in Blood Pressure
timeFrame: Baseline, Week 16, Week 32
measure: Change in HbA1C
timeFrame: Baseline, Week 16, Week 32
measure: Change in Total Cholesterol / HDL-cholesterol
timeFrame: Baseline, Week 16, Week 32
measure: Change in Dietary Intake (daily eating patterns)
timeFrame: Baseline, Week 16, Week 32
measure: Change in Moderate to vigorous physical activity (MVPA) and sedentary behavior
timeFrame: Baseline, Week 16, Week 32
measure: Change in sleep behavior (daily sleeping patterns)
timeFrame: Baseline, Week 16, Week 32
measure: Change in home food and physical activity environment
timeFrame: Baseline, Week 16, Week 32
measure: Change in demographic and social and environmental risk factors for T2D
timeFrame: Baseline, Week 16, Week 32
Other outcomes:
Locations:
city: Tucson
country: United States
facility: El Rio Community Health Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Melanie D Hingle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: David G Marrero, PhD
role: PRINCIPAL_INVESTIGATOR
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