Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS

Summary

We will tailor a telehealth obesity intervention for obese patients with MS (figure 2). Half of the patients will be randomly assigned to 24 weekly hour-long group weight loss sessions and 6 monthly individual sessions; half will be assigned to a brief education/Treatment as Usual (TAU) control condition. Participants assigned to the control condition will also receive the active treatment 6 months following their enrollment. As such, we will have feasibility, acceptability, and outcome data for all patients who enroll and complete the intervention. During outpatient recruitment, clinicians will ask obese patients (WHtR \>.57, BMI \>29) if they would be willing to be contacted about a study investigating a weight loss intervention for patients with MS. Patients who express interest and respond to advertisements will be screened by telephone and via review of medical records. Patients who meet initial eligibility criteria will be invited for a baseline evaluation where they will be formally consented, complete questionnaires and behavioral tasks, and undergo a standardized physical exam. They will be monitored using actigraphy for 10 days. They will then be randomized to the group telehealth obesity intervention or TAU. At 6 months, all participants will undergo a second in-person follow-up assessment and TAU participants will begin the telehealth intervention. At 12 months, participants will undergo a third in-person assessment, providing treatment outcome data for all study participants and long-term weight maintenance data for patients initially assigned to the telehealth obesity intervention. At 18 months, participants initially assigned to the TAU control condition will undergo a 4th assessment, providing weight maintenance data for all enrolled participants.

Conditions

• Multiple Sclerosis
• Obesity

Interventions

BEHAVIORAL

behavioral telehealth

Participants will receive 24 weekly group phone counseling sessions. Each session will last approximately 60 minutes and begin with an open-ended check-in question, followed by review of weekly self-monitoring data, question and answer time, and end with a new didactic topic of the week addressing diet, physical activity, or behavior change topics. Participants will be instructed to follow a diet that is reduced to 1200-1500 kcal/day and includes ≥ 5 fruit and vegetable (FV) servings per day, \<25% kcal from fat, and 20-30 g of fiber. Physical activity will be gradually increased through a guided home-based program. Throughout the intervention, self-monitoring will be emphasized as a key behavioral weight loss strategy.

OTHER

Treatment as Usual

Treatment as Usual

Sponsors & Collaborators

• National Multiple Sclerosis Society

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• Children's Mercy Hospital Kansas City

  collaborator OTHER

• Jared Bruce

  lead OTHER

Principal Investigators

• Jared Bruce, PhD · University of Missouri, Kansas City

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-01

Primary Completion

2022-10-20

Completion

2023-09-20

Countries

• United States

Study Locations