A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program

NCT00907660 | Completed Phase 2

• 2 other identifiers: 09-0054K24DK065018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that individuals provided with 1 meal per day of portion-controlled foods (shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals per day of portion-controlled foods. The study is designed to assess whether equal weight loss can be achieved at a lower cost to the health care system (or health care payer), with patients contributing some of the cost of their own treatment.

Conditions

Obesity

Keywords

Obesity; Weight loss; Meal replacements; Health services research

Outcome Measures

Primary Outcomes (1)

• Weight change

  14 weeks

Secondary Outcomes (4)

• Health-related quality of life

  14 weeks

• Blood pressure

  14 weeks

• Waist circumference

  14 weeks

• Body mass index

  14 weeks

Study Arms (2)

Full Dose

ACTIVE COMPARATOR

Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 2 meals per day of portion-controlled foods (shakes and entrees)

Behavioral: Weight loss counseling; Dietary Supplement: Portion-Controlled Foods

Half dose

EXPERIMENTAL

Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 1 meal per day of portion-controlled foods (shakes and entrees)

Behavioral: Weight loss counseling; Dietary Supplement: Portion-Controlled Foods

Interventions

Weight loss counseling BEHAVIORAL

Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day

Also known as: Dietary counseling, Behavior modification, Diet and exercise

Full Dose; Half dose

Portion-Controlled Foods DIETARY_SUPPLEMENT

Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.

Also known as: Meal replacements

Full Dose; Half dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from the University Medicine Denver, University Medicine Anschutz, and A.F. Williams clinics meeting the following criteria
• Age 18 or older
• Able to keep a food record for 3 days prior to study entry
• Able to give informed consent
• Willing to accept randomization to either treatment condition, to attend all sessions, and to complete study-related assessments
• Body mass index (BMI) ≥ 30 kg/m2 and \< 50 kg/m2
• Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
• Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
• Elevated blood pressure (≥130/85), including hypertension (≥140/90); individuals taking anti-hypertensive medication qualify automatically
• Hypertriglyceridemia (TG ≥ 150); individuals taking lipid-lowering medications qualify automatically
• Decreased high-density lipoprotein (HDL) cholesterol (\< 40 for men, \< 50 for women)
• Obstructive sleep apnea

You may not qualify if:

• Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
• Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
• Weight gain or loss of ≥5% of weight in the past 6 months; patients who have not been weight stable may be re-screened in 3 months
• Concurrent use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
• Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
• Prior or planned bariatric surgery
• Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Center for Human Nutrition

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Nutrition Assessment; Behavior Therapy; Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Psychotherapy; Behavioral Disciplines and Activities; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Adam G Tsai, MD, MSCE

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

US (1)