Healthy Eating, Physical Activity, and Glycemic Control in Young Children With T1D

NCT02343146 | Completed DMC

• 2 other identifiers: 5649DP3DK103998
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of type 1 diabetes (T1D) in young children (age \<5 years) is rising. The burden of responsibility for disease management rests on parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. This occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, and parenting stress is elevated. Despite behavioral interventions that have demonstrated success in reducing rates of parent stress and improving child behavior, improvements in young children's glycemic control has not been sufficiently achieved. The investigators' research will attempt to achieve this goal through the development and pilot of an innovative behavioral intervention for T1D in parents of young children. The focus of the intervention is on improving young children's nutrition and physical activity through the use of parent consultants and delivery of intervention through phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary caregivers of young children (\<5 years) diagnosed with T1D for at least 6 months will receive the intervention and then be assessed at 3- and 6- months post baseline on indices of behavior and glycemic control (including continuous glucose monitoring). Participants will also complete in-depth surveys to provide qualitative as well as quantitative data. At the end of Phase 1, the data will be analyzed and used to develop the intervention further for Phase 2. During Phase 2, 60 participants and their children will be randomized to either the revised intervention (treatment) or usual care (control) condition. Intervention components include: T1D management support delivered by trained lay parent consultants, and T1D parenting strategies specific to improving eating and physical activity behaviors delivered by bachelor's level behavioral assistants via telephone and text messaging. Biomedical and psychosocial measurements (including HbA1c, physical activity, nutrition, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3- and 6-months post baseline. The results of this work will ultimately lead to a program which can improve young children's T1D management and glycemic control that can be translated into a variety of clinical practice settings.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Glycemic Control/HbA1c

  Change in glycemic control from baseline to 6 months post intervention

  6 months post intervention

Secondary Outcomes (1)

• Child eating as measured by Remote Food Photography by the parent

  6 months post intervention

Study Arms (2)

Type One Training (TOT)

EXPERIMENTAL

The intervention group will receive the proposed intervention composed of peer parent consultants, telephone and in-person sessions with a trained interventionist, and SMS text messaging aimed at improving child glycemic control through improved nutrition and physical activity.

Behavioral: Type One Training (TOT)

Comparison

NO INTERVENTION

The comparison group will receive usual care with the diabetes team.

Interventions

Type One Training (TOT) BEHAVIORAL

The intervention is comprised of a number of modes of delivery including in person, use of parent peer consultant, telephone intervention, and text messaging. The intervention is based on Social Cognitive Theory and previous work of the investigators.The focus of the intervention is on working with parents to improve child eating and physical activity behaviors as a means of improving glycemic control in very young children with type 1 diabetes.

Type One Training (TOT)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• parent of a child age 1-5 and their target child (children are considered secondary participants)
• child with a minimum of 1 year duration of T1D
• parents must have ready and consistent access to a mobile telephone with text messaging capability

You may not qualify if:

• Parent participants cannot have serious mental illness or developmental disability that would limit participation
• Child participants cannot have other life-threatening disease (e.g., cancer, cystic fibrosis) or developmental disability (e.g., autism, mental retardation)
• Parent participants must be able to adequately understand, speak, and read English

Sponsors & Collaborators

• Randi Streisand: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Mackey ER, Tully C, Rose M, Hamburger S, Wang J, Herrera N, Cogen F, Henderson C, Monaghan M, Hornack S, Streisand R. Promoting glycemic control in young children with type I diabetes: Results from a pilot intervention for parents. Fam Syst Health. 2022 Jun;40(2):239-251. doi: 10.1037/fsh0000672.

  PMID: 35666897 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Randi Stresiand, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 21, 2015
• Study Start: December 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Locations

US (1)