Cell Phone Intervention in Young Adults



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 35
Updated:11/15/2017
Start Date:November 2010
End Date:October 2014

Use our guide to learn which trials are right for you!

Weight gain accelerates during early adulthood, and leads to the health consequences of
obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll
middle-aged adults. This study tests the hypothesis that a weight loss intervention that
builds on prior research evidence but is enhanced with technological innovations will lead to
weight loss in a diverse group of overweight and obese adults aged 18-35 years. The
technology intervention, using cell phone applications, will be compared to an "advice only"
control group and to a group receiving a more traditional personal coaching intervention.

Trials in middle aged adults indicate that weight loss can be achieved and sustained with
frequent contact over a long period of time, frequent self-monitoring, social support and
motivational counseling. However, it is unclear whether this strategy would work in younger
adults. Based on life stage, cultural context, environmental circumstances, and marketing
pressures, behavioral intervention may need to be substantially modified to be effective in
young adults. Even more adaptation will be required for intervention to be effective in young
adults from racial/ethnic minority groups. The proposed intervention builds on prior evidence
with innovations directed at increasing effectiveness in young adults.

Using cell phones to deliver a weight control intervention in this age group has the
potential to be engaging, enjoyable, practical, cost-effective, sustainable, and broadly
disseminated. We propose a trial in which a highly innovative but more risky intervention
based almost entirely on use of cell phone technology and a second more incremental
innovation over traditional behavioral intervention are each compared to a usual care control
group. We will recruit a diverse target population of overweight/obese, generally healthy
young adults, comprising approximately 35% non-Latino Whites, 35% non-Latino Blacks, and 30%
Latinos, to be randomized to: 1) Usual care control: Educational materials and information
but no behavioral intervention; 2) Cell-phone intervention: similar education and knowledge
as the control group, but thereafter a behavioral intervention will be delivered almost
exclusively via cell phone, particularly using the self-monitoring and social networking
features of this technology; 3) Personal contact with cell-phone enhancement: personal
contact intervention enhanced by cell-phone for self-monitoring.

The post-randomization intervention period will last 24 months. The primary outcome is change
in weight 12 months post-randomization; an important secondary outcome is weight change at 24
months.

The formative phase will focus largely on technology/intervention development.

To assess maintenance of weight loss, after completion of the primary outcome assessment (24
months post-randomization), participants in the control group are followed observationally;
those in the cell-phone and personal coaching interventions are re-randomized to either
continue intervention or stop intervention with observational follow-up. All participants who
agree to participate in this maintenance phase are followed for an additional 2-3 years with
data collection every 6-12 months.

Inclusion Criteria:

- Age 18-35 years;

- BMI >=25;

- Using a cellphone.

Exclusion Criteria:

- Diabetes mellitus;

- Pregnant or nursing;

- Use of weight loss medications, systemic steroids, antipsychotics, or diabetes
medication;

- Prior weight loss surgery;

- Cardiovascular (CVD) event in past 6 months;

- Current malignancy.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials