Pilot randomized trial of a telephone-delivered physical activity and weight management intervention for individuals with lower extremity amputation.

BACKGROUND

Obesity and inactivity are common and burdensome for people with lower extremity amputation (LEA). The extent to which home-based physical activity/weight management programs are effective and safe for people with LEA is unknown. Translating effective interventions for understudied disability groups is needed.

OBJECTIVE

To test the feasibility, acceptability, and safety of a weight management and physical activity intervention and obtain preliminary efficacy estimates for changes in weight, body composition, and physical functioning.

METHODS

Eligibility criteria included: LEA ≥1 year prior, 18-69 years of age, overweight or obese and living in the Seattle area. The intervention arm received self-monitoring tools (e.g., pedometer, scale) and written materials, a single exercise counseling home visit by a physical therapist, and up to 11 telephone calls from a health coach over 20 weeks that involved motivational interviewing to set specific, attainable, and measurable goals. The self-directed control group received the same tools and materials but no home visit or coaching calls.

RESULTS

Nineteen individuals consented to participate, 15 were randomized (mean age = 56, 73% male, 80% transtibial amputation) and 11 completed 20-week follow-up assessments. The intervention was acceptable and safe. Coached participants had greater decreases in waist circumference (mean difference between groups over 20 weeks, baseline values carried forward: -4.3 cm, 95% CI -8.2, -0.4, p = 0.03) and fat mass (-2.1 kg, 95% CI -3.8, -0.4, p = 0.02).

CONCLUSIONS

The home-based intervention was promising in terms of efficacy, safety and acceptability. Inclusion of multiple trial centers and increased use of technology may facilitate recruitment and retention.