A Family-Based Approach to Treat Obesity and Its Co-morbidities in Youth With Type 1 Diabetes (T1D) and Their Parents

The investigators are conducting a 6-month (26 weeks) pilot trial enrolling 20 patients (6-17-year-old) with T1D and overweight/obesity and at least one parent with overweight/obesity and at least one associated co-morbidity, such as hypertension, pre-diabetes/T2D, or hyperlipidemia. The investigators realize that the age range chosen encompasses different developmental ages and are prepared to make some adaptations based on the intellectual and developmental abilities of the youth. For example, young children react very well to games related to food choices. Participants will have T1D duration >1 year (to exclude patients in the partial remission period), receive insulin therapy via pump or multiple daily injections, and wear a continuous glucose monitor. Both insulin regimens paired with continuous glucose monitor allow comparable potential to achieve optimal diabetes control. This study will test the feasibility of delivering an FBT intervention with a strong behavioral component to treat overweight in BOTH child and parent. The investigators will provide the participants with Body Trace Weight scales and instruct parents and youth to check their weight twice/week. The purpose of weight checking between in-person meetings is for the family coach to help the parent (and the child is old enough) relate weight changes to diet and activity habits/healthy behaviors and to develop plans to address weight gain relapse when needed. The choice of the Body Trace Weight scale is because it is a cellular enabled scale that will work even if there is a lapse in Wi-Fi availability and is user friendly without complicated set up procedures. Moreover, the investigators have already purchased them and will not need funding for them.

The intensity of the proposed schedule is in keeping with the treatment dose recommended by the United States Preventive Task Force recommendations. The coaching sessions will occur weekly for nine weeks (week 0,1,2,3,4,5,6, 7, 8), followed by sessions every two weeks for two months (wks. 10,12,14,16, 18), and then 2 sessions at a monthly interval (wks. 22 and 26). As described in the table below, the intensity of contact needs to be greater initially because this facilitates change in habits. However, "lack of time" is a major barrier to the acceptance of FBT programs for treatment of overweight and ultimately in the translation and dissemination of successful programs. Therefore, to overcome this barrier, after the initial four in person (IP) sessions, the investigators will alternate IP with virtual (V) meetings. Moreover, the investigators will coordinate the standard of care diabetes follow-ups (needed every 10-12 weeks) at the same time of the coaching sessions (IP + clinic at week 0-12 and 26).

Wk 0 1 2 3 4 5 6 7 8 10 12 14 16 18 22 26 IP+ CLINIC IP IP IP V IP V IP V V IP + CLINIC V IP V IP IP + CLINIC The coordination of the sessions with the standard of care visit will also involve the patient's diabetologist in following the patient's progress, providing positive feedback and learning from this program. From a practical standpoint, out of the 14 planned sessions, 6 will be virtual sessions, 3 will be in-person coordinated with the diabetes standard of care follow-up outpatient appointment, and seven would be in-person sessions. The investigators have experience with virtual delivery of FBT in the primary care setting during the COVID pandemic. Moreover, patients with T1D are accustomed to the use of digital health to upload their pump and sensors/glucose monitors. The investigators have conducted a 4-week pilot on the use of Wi-Fi scales in ten children 2-8 years old and their mothers (6/10 overweight or obese) who were instructed to monitor their weight and the child's weight twice week for a total of 8 times. 8/10 mothers monitored their weight and that of their child 7/8 times.

The investigators have considered the possibility of group sessions which foster learning and peer support and are cost-effective. Group education has been adopted especially in adults with T2D. While the investigators have conducted FBT group meetings in many instances in the past, they have been coupled with 1:1 meeting to tailor coaching to the particular needs of a participant and to "make up" missed group sessions. T1D is a chronic and very taxing disorder for patients and families. The coordination of group meetings imposes a "fixed day and time" regimen that cannot be met by many parents who need flexibility and tends to exclude single parents and those families who have health and socio-economic inequities, who could benefit the most from coaching. In the recently completed PLAN grant, a multicenter FBT implemented in the primary care setting the investigators adopted a 1:1 strategy which has allowed us to recruit 43% of minority families and 17% with income at the poverty line or below.

Our FBT curriculum, which has been delivered successfully in the specialty and primary care settings, has 3 components: 1. Meal planning including quality of carbohydrates and glycemic index for both parents and children while ensuring that youth have a balanced meal plan with adequate amounts of carbohydrates for optimal growth. Our FBT has a focus on "Food Literacy" including healthy food selection and sourcing of affordable healthy food, food preparation and preplanning, social engagement tailoring the meal plan to the needs to the family in socio cultural appropriate way and also feasibility based on logistics and economic aspects; 2. Physical activity (PA) component with shaping strategy to allow for a progressive shaping of easy PA starting, if needed, with as little as with 10 minutes of walking/day and strategies to incorporate PA in daily routines, family, and social activities; 3. Extensive behavioral component which has been shown to be very powerful in FBT for obesity and will be tailored to the needs of the patient with T1D. The program will focus on energy reduction, increased PA, and behavioral techniques to develop and sustain healthy habits conducive to reach healthy weight while balancing glycemic targets.