Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00054925 |
| Other study ID # |
Pro00013066 |
| Secondary ID |
U01HL068734 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
February 13, 2003 |
| Last updated |
March 6, 2012 |
| Start date |
January 2003 |
| Est. completion date |
October 2009 |
Study information
| Verified date |
March 2012 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Interventional
|
Clinical Trial Summary
To determine the effectiveness of continuous patient contact on weight loss maintenance.
Description:
BACKGROUND:
Overweight/obesity is the second leading cause of death in the US, and is growing in
prevalence at an alarming rate. Control of overweight/obesity is increasingly recognized as
a high national priority because of its contribution to cardiovascular (CVD) risk factors
and ultimately to CVD itself. The short-term success of behavioral interventions for weight
loss has been repeatedly documented. Unfortunately, because weight re-gain is extremely
common, a disappointingly, small proportion of individuals achieve long-term weight control.
Of the factors that are associated with sustained weight loss, one of the most important is
continued intervention with frequent contacts.
DESIGN NARRATIVE:
The study is a multi-center, randomized, controlled trial [Weight Loss Maintenance Trial
(MAINTENANCE)] to determine the effects of two innovative behavioral interventions, each
designed to maintain frequent contacts, compared to a usual care control group. Overweight
and obese individuals (60% women, 40% African Americans) who are taking medication for
hypertension, dyslipidemia and/or type 2 diabetes will enter a 6-month, weight loss program.
Those 800 individuals who lose at least 4 kg (approximately 9 pounds) will then be
randomized into one of three groups: a Personal Contact (PC) Intervention that provides
monthly personal contacts with a trained interventionist, primarily via telephone; an
Interactive Technology (IT) Intervention that provides frequent contacts through a
state-of-the-art interactive web-based program supplemented by other communication
technologies; or Usual Care (UC). The primary outcome will be weight change from the end of
the initial weight loss program to the end of the 30-month weight maintenance intervention
period. Other outcomes will include weight change in subgroups, prevalence of CVD risk
factors, measures of behavior change, and cost of implementation. For each outcome, the
Personal Contact and Interactive Technology interventions will be compared to Usual Care
and, if different from Usual Care, to each other. To successfully combat the obesity
epidemic, clinicians and health care systems must have options that are effective and
feasible and that can be provided to large numbers of individuals.
Phase II intervention completed: July 2007
Phase III intervention completed: October 2009
