Weight Loss Maintenance in Primary Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00455780

Acronym

PrimaryCare

Enrollment

238

Registered

2007-04-04

Start date

2005-01-31

Completion date

2010-08-31

Last updated

2011-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Eating, Dieting, Meal replacements, Energy Density, Weight Loss Maintenance

Brief summary

After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.

Interventions

BEHAVIORALWeight Loss Phase

Weight loss using CBT and meal replacements

BEHAVIORALContinued CBT

Using CBT during weight loss maintenance

BEHAVIORALreduced energy density education

Additional nutritional learning

BEHAVIORALcontinued use of meal replacements

continued use of meal replacements during weight loss maintenance

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* BMI of 30, or BMI of 27 with weight-related comorbidities * Access to a telephone and voice mail/answering machine * MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)

Exclusion criteria

* Previously/currently diagnosed with an eating disorder * Current bi-polar, depression, substance abuse, or dependence disorder * Living with someone already enrolled * Enrolled in another weight loss program * Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease) * Myocardial infraction within the past three months * Unstable angina * Nephrotic syndrome/malabsorptive disease * Gout attack within the past year * Lactating/pregnant (or planning within next two years) * Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease

Design outcomes

Primary

Measure	Time frame
Weight	baseline, 3 months, 12 months, 24 months, 36 months

Secondary

Measure	Time frame
Body composition	baseline, 3 months, 12 months, 24 months, 36 months
Blood work results	baseline, 3 months, 12 months, 24 months
Scores on questionnaire-based measures	baseline, 3 months, 12 months, 24 months, 36 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026