Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Family-Focused Mobile Health Intervention: Targeting Family Behaviors to Improve Type 2 Diabetes Management Among Adults
This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to ascertain if family-focused content delivered to the patient can improve the patients' family support for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.
Family members perform diabetes-specific behaviors that are helpful and/or harmful to the
adult managing type 2 diabetes. Family behaviors are strongly associated with patients'
adherence to diet and exercise: supportive family behaviors with more adherence and harmful
family behaviors with less adherence. This six-month intervention seeks to increase
supportive and reduce harmful family behaviors, and to improve diabetes-related self-efficacy
and adherence to diet and exercise recommendations among adult patients with content that can
be delivered via basic mobile phones (i.e., phone calls and text messages).
FAMS components include:
- Six 20-30 minute coaching sessions with patient participants by phone focusing on
helpful/unhelpful/desired family behaviors relevant to the patients' self-identified
daily diet or exercise goal (occurs after enrollment and monthly for six months)
- Text messages to the patient to support him/her in meeting the identified daily goal (4
per week)
- The option to invite an adult support person to receive text messages (3 per week)
encouraging the support person to discuss the patient's self-care goal to provide
opportunities for the patient to practice skills discussed during phone coaching
This intervention evaluation is nested within a larger randomized controlled trial (RCT; see
NCT02409329) which evaluates REACH, a text messaging intervention to improve participants'
adherence to self-care and glycemic control. We will evaluate these interventions with a
three arm trial. Participants will be randomized to receive REACH only, REACH+FAMS, or an
active control. Participants assigned to REACH+FAMS will receive the above described
components for the first six months of the trial, and then REACH only until the end of the
trial. Analyses will examine outcomes of FAMS at 3 and 6 months.
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