NCT02578199

Brief Summary

Motivational interviewing and nutritional counseling for weight loss in primary care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

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

October 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 1, 2017

Completed
Last Updated

March 30, 2020

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 14, 2015

Results QC Date

June 13, 2017

Last Update Submit

March 26, 2020

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Body Weight in Pounds

    Body weight in pounds measured 3 months after starting treatment.

    3 months

Secondary Outcomes (1)

  • Body Weight in Pounds

    6 months

Study Arms (1)

motivational interviewing and nutrition

EXPERIMENTAL

Motivational interviewing and nutritional counseling.

Behavioral: motivational interviewing and nutrition

Interventions

motivational interviewing and nutritionBEHAVIORAL

Motivational Interviewing and Nutritional Counseling

motivational interviewing and nutrition

Eligibility Criteria

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

You may qualify if:

  • BMI 25-55
  • Daily access to internet and phone
  • Recruited through local primary care offices.
  • Age 18-65

You may not qualify if:

  • Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
  • Meets criteria for current substance abuse/dependence
  • Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
  • Pregnant, breastfeeding, or plans to become pregnant during the treatment period
  • Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
  • Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
  • Uncontrolled diabetes, thyroid conditions, or hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

  • Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. 12 Months later: Motivational interviewing plus nutrition psychoeducation for weight loss in primary care. Eat Weight Disord. 2021 Aug;26(6):2077-2081. doi: 10.1007/s40519-020-00994-5. Epub 2020 Sep 7.

    PMID: 32894453DERIVED

  • Barnes RD, Ivezaj V, Martino S, Pittman BP, Paris M, Grilo CM. Examining motivational interviewing plus nutrition psychoeducation for weight loss in primary care. J Psychosom Res. 2018 Jan;104:101-107. doi: 10.1016/j.jpsychores.2017.11.013. Epub 2017 Nov 28.

    PMID: 29275778DERIVED

  • Barnes RD, Ivezaj V, Martino S, Pittman BP, Grilo CM. Back to Basics? No Weight Loss from Motivational Interviewing Compared to Nutrition Psychoeducation at One-Year Follow-Up. Obesity (Silver Spring). 2017 Dec;25(12):2074-2078. doi: 10.1002/oby.21972. Epub 2017 Oct 31.

    PMID: 29086484DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Motivational InterviewingNutritional Status

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Results Point of Contact

Title
Dr. Rachel Barnes
Organization
YALE
rachel.barnes@yale.edu
203-785-6395

Study Officials

  • Rachel Barnes, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2015

First Posted

October 16, 2015

Study Start

December 1, 2015

Primary Completion

December 2, 2016

Study Completion

March 10, 2017

Last Updated

March 30, 2020

Results First Posted

August 1, 2017

Record last verified: 2016-11

Locations

US(1)