Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods.

BACKGROUND: Achievement of 5-10% weight loss (WL) among older adults living with obesity considerably improves prognosis of health-related outcomes; however, concomitant declines in bone mineral density (BMD) limit overall benefit by increasing fracture risk. Declines in mechanical loading contribute to WL-associated BMD loss, with pilot data signaling the addition of external weight replacement (via weighted vest use) during intentional WL mitigates bone loss at weight bearing sites to a similar degree as resistance exercise training (RT). Definitive data in support of weighted vest use as a potential strategy to mitigate WL-associated bone loss in this population are needed. METHODS: In the Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health trial (NCT04076618), 192 older adults (60-85 years) who are overweight (BMI ≥ 27 kg/m2) with at least one obesity-related risk factor or obese (BMI = 30-40 kg/m2) will be randomly assigned to participate in one of three 12-month intervention groups: WL alone, WL + weighted vest use (WL + VEST), or WL + RT. The primary aim is to determine the effects of WL + VEST compared to WL alone and WL + RT on indicators of bone health and subsequent fracture risk. DISCUSSION: Determining effective, translatable strategies that minimize bone loss during intentional WL among older adults holds public health potential. The INVEST in Bone Health trial offers an innovative approach for increasing mechanical stress during intentional WL in the absence of RT. If successful, findings from this study will provide evidence in support of a scalable solution to minimize bone loss during intentional WL among older adults with obesity.

Feasibility and safety of a group physical activity program for youth with type 1 diabetes.

BACKGROUND/OBJECTIVE: Many adolescents with type 1 diabetes do not achieve 60 minutes of daily moderate-to-vigorous intensity physical activity (MVPA). Recognizing the importance of peer influence during adolescence, we evaluated the feasibility and safety of a group MVPA intervention for this population. METHODS: Eighteen adolescents with type 1 diabetes (age 14.1 ± 2 .3 years, female 67%, black or Latino 67%, median body mass index 92%'ile, A1c 79.9 ± 25.1 mmol/mol, 9.5 ± 2.3%). Intervention sessions (35 minutes MVPA and 45 minutes discussion) occurred 1×/week for 12 weeks. Feasibility and safety metrics were enrollment, completion of intervention and assessments, cost, and hypoglycemia rates. Participants completed MVPA (accelerometry), and exploratory nutritional, psychosocial, clinical, and fitness variable assessments at baseline, 3 months, and 7 months. Hedges' effect sizes were calculated. RESULTS: Enrollment was 16%, and intervention completion was 56%. Assessment completion at 7 months was 67% for MVPA, nutrition, and fitness, 83% for psychosocial assessments, and 94% for clinical assessments. Cost was $1241 per completing participant. One episode of mild hypoglycemia occurred during the sessions (0.6%). Self-reported daily fruit/vegetable servings (d = -0.72) and diabetes self-management behaviors decreased over time (d = -0.40). In the 10 completers, endurance run score improved (d = 0.49) from low baseline levels, while systolic blood pressure decreased (d = -0.75) and low-density lipoprotein increased (d = 0.49) but stayed within normal ranges. CONCLUSIONS: The protocol for the group MVPA intervention was safe and had some feasibility metrics meriting further investigation. MVPA levels and glycemic control remained suboptimal, suggesting the need for more intensive interventions for this population.