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Novel Approaches to Weight Loss Maintenance

19 Years
70 Years
Not Enrolling
Weight Loss Maintenance

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Trial Information

Novel Approaches to Weight Loss Maintenance

Obesity is a major public health problem in the United States. Increases in obesity
prevalence over the last four decades have been dramatic in all age and social groups,
heightening concern about health risks for children, adolescents, and adults. Currently,
over half of US adults are overweight and upward trends in prevalence show no sign of
slowing. A continuation of current trends seems quite likely to lead to substantial
increases in the number of people affected by obesity-related health conditions and in
premature mortality. The primary treatment for obesity continues to be behavioral weight
loss therapy, an approach that uses behavioral strategies (e.g., self-monitoring, stimulus
control, problem-solving) to help participants adhere to dietary and physical activity
recommendations. Significant progress has been made with respect to short term weight loss
research over the past twenty years, with short term weight losses approximately doubling
during this time period. Unfortunately, long term weight losses remain disappointing. The
typical pattern is for maximum weight loss to occur at 6 months, with weight regain
following. During the year following treatment, participants typically regain 30% to 50% of
their initial weight loss. Follow-up beyond 1 year indicates a pattern of continued weight

Though long term weight loss maintenance remains a critical challenge for obesity treatment,
important information regarding successful weight loss maintenance (e.g., high levels of
physical activity, self-weighing, maintenance of a low-fat, low-calorie diet) has been
derived from the National Weight Control Registry led by Drs Wing and Hill. Treatment
studies have incorporated such strategies to enhance maintenance; however, the most
intensive treatment phase typically occurs during weight loss initiation with the
maintenance phase occurring after treatment novelty has faded. Although increasing treatment
duration improves weight loss, there is a point of diminishing returns as people eventually
stop attending intervention sessions. An alternative strategy to provide the critical
support necessary for weight loss maintenance may be to recruit people who have recently
lost weight to a maintenance-focused intervention

We will recruit up to 400 adult men and women who have recently lost at least 10% of their
body weight and randomize them to either a Self-Directed Intervention or a Guided
Intervention . Self- Directed participants will receive a core set of print materials
describing key behaviors and skills necessary for successful weight loss maintenance and
will review these materials with an intervention coach during two phone sessions. Guided
participants will take part in a set of ten core phone sessions addressing key factors
relevant to weight maintenance (e.g., high levels of physical activity). After completing
these sessions, Guided participants will receive 8 monthly check in calls and then bimonthly
calls for the rest of the study. Guided participants are also asked to report their weight
weekly, either via the Keep It Off website, email or voicemail. Those who experience
weight gain will receive outreach calls to assist them in reversing their recent weight
gain. They will also receive bi-monthly tailored feedback reports based on whether they are
maintaining, losing or gaining weight. We hypothesize that those in the Guided arm of the
study will regain less weight than those in the self-directed arm.

Inclusion Criteria:

- Between the ages of 19 and 70

- HealthPartners members for 11 out of the past 12 months

- Have lost at least 10% of body weight in the last 12 months

Exclusion Criteria:

- Lost weight via gastric by-pass surgery

- Modified Charlson scores >=3

- Nonskin cancer

- Congestive heart failure

- Coronary heart disease

- Psychotic illness

- Substance abuse

- Terminal illness

- Diagnosed eating disorder

- BMI<20.5 or >45

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Weight: Weight change in kilograms at 24 month follow-up. We hypothesize that Guided participants will regain less weight than the Self-Directed participants.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Nancy E. Sherwood, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

HealthPartners Institute for Education and Research


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

July 2012

Related Keywords:

  • Weight Loss Maintenance
  • Weight loss maintenance.
  • Interactive phone and mail-based intervention.
  • Weight Loss



HealthPartners Research FoundationMinneapolis, Minnesota