NCT01220089

Brief Summary

The study has two primary aims. The first aim is to assess the efficacy of adding in-person visits to the use of portion-controlled foods for long-term weight loss. The second aim is to assess the use of trained lay counselors for the maintenance of weight loss. The primary endpoint of the study will be changes in weight. Secondary endpoints will include changes in body mass index (BMI), cardiovascular risk factors, health-related quality of life, and cost-effectiveness. The addition of in-person visits with the weight loss counselor is predicted to lead to greater long-term weight loss than the use of portion-controlled foods alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

September 23, 2010

Last Update Submit

January 28, 2020

Conditions

Obesity

Keywords

obesityweight loss

Outcome Measures

Primary Outcomes (1)

  • weight change

    Weeks 1-4, 6, 8, 10, 12, 15, 18, 21, 24 & 72

Secondary Outcomes (6)

  • change in glucose

    baseline, 6 months & 18 months

  • change in blood pressure

    baseline, 6 months & 18 months

  • change in waist circumference

    baseline, 6 months & 18 months

  • change in lipids

    baseline, 6 months & 18 months

  • change in health-related quality of life

    baseline & 18 months

  • +1 more secondary outcomes

Study Arms (2)

Standard maintenance

ACTIVE COMPARATOR

During months 7 to 18, individuals in the Standard Maintenance condition will receive informational handouts by mail (or e-mail) regarding weight maintenance.

Behavioral: Standard maintenance

Intensified Maintenance

ACTIVE COMPARATOR

During months 7 to 18, individuals in the Intensified Maintenance condition will continue to have monthly in-person visits with the weight loss counselor ("Weight Coach").

Behavioral: Intensified maintenance

Interventions

Standard maintenanceBEHAVIORAL

Participants will receive written materials in months 7-18

Standard maintenance
Intensified maintenanceBEHAVIORAL

Participants will continue with in-person counseling visits in months 7-18

Intensified Maintenance

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 79
  • Able to give informed consent
  • Able to keep a food record for 7 days prior to study entry and to complete 2 screening visits and a blood draw prior to enrollment
  • Willing to attend all counseling sessions, to complete study-related assessments, and to be randomized to a treatment condition after 6 months of treatment
  • Has a regular primary care physician (if referred from outside the University of Colorado system)
  • 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
  • Hyperlipidemia/dyslipidemia, including any of the following: hypertriglyceridemia (TG ≥ 150); low HDL cholesterol (\< 40 for men, \< 50 for women); or taking lipid-lowering medications
  • 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
  • Myocardial infarction or stroke within the past 6 months
  • Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled
  • Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when controlled
  • Weight gain or loss of ≥ 5% of weight in the past 6 months; patients who have not been weight stable may be re-screened
  • Chronic 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)
  • Untreated major depression (PHQ-9 score ≥ 20)
  • Pregnant or trying to become pregnant
  • Social situation precluding participation in a research study (e.g., need to care for a small child or an elderly parent)
  • Prior or planned bariatric surgery
  • Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Nutrition

Denver, Colorado, 80220, United States

Location

Related Publications (1)

  • Tsai AG, Juarez-Colunga E, Felton S, Speer RB, Bessesen DH, Atherly AJ. Medication costs during an 18 month clinical trial of obesity treatment among patients encountered in primary care. BMC Obes. 2015 May 29;2:24. doi: 10.1186/s40608-015-0054-4. eCollection 2015.

    PMID: 26217539DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Adam G Tsai, MD, MSCE

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

October 13, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2013

Study Completion

August 1, 2015

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

US(1)