NCT01646086

Brief Summary

To achieve the long term goal of strengthening behavioral weight loss programs, the purpose of this project is to test an enhanced, daily weight tracking instruction against the current standard of care (weekly weight tracking) and an alternative mode of care (no weight tracking). The investigators postulate that daily weight tracking will boost ongoing awareness of and engagement in dietary intake and physical activity monitoring, thus improving weight loss outcomes. The central hypothesis of the study is that daily weight tracking will improve weight loss processes and outcomes relative to less frequent weight tracking, without adverse effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

3.2 years

First QC Date

July 18, 2012

Last Update Submit

October 30, 2019

Conditions

Weight Loss

Keywords

Weight LossSelf-WeighingWeight Tracking

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight Over Time

    Weight (in kilograms) will be measured by study staff using a calibrated digital scales with participants wearing light clothing and no shoes. Height (in centimeters) will be measured by study staff at baseline only using a portable stadiometer. BMI (kg/m2) will be calculated from these measurements

    baseline, 6 months, 12 months, 18 months, and 24 months

Secondary Outcomes (15)

  • Demographic Measures

    baseline

  • Weight Tracking and Self-Monitoring Adherence

    throughout intervention

  • Perceptions of Weight Tracking

    6 months, 12 months, 18 months, and 24 months

  • Barriers to Weight Tracking

    baseline, 6 months, 12 months, 18 months, and 24 months

  • Self-Efficacy for Weight Loss Behaviors

    baseline, 6 months, 12 months, 18 months, and 24 months

  • +10 more secondary outcomes

Study Arms (3)

weekly weight tracking

EXPERIMENTAL

12 month behavioral weight loss intervention

Behavioral: 12 month behavioral weight loss intervention

daily weight tracking

ACTIVE COMPARATOR

12 month behavioral weight loss intervention

Behavioral: 12 month behavioral weight loss intervention

no weight tracking

ACTIVE COMPARATOR

12 month behavioral weight loss intervention

Behavioral: 12 month behavioral weight loss intervention

Interventions

12 month behavioral weight loss interventionBEHAVIORAL

The intervention for all groups will follow a standard behavioral weight loss protocol. Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to keep daily diet and physical activity logs.

daily weight trackingno weight trackingweekly weight tracking

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women and men
  • years of age
  • BMI between 25.0 and 39.9 kg/m2 (overweight to obese)
  • interest in joining a weight loss program
  • have a computer, email, and wifi connection at home
  • live in the Minneapolis/Saint Paul, Minnesota area

You may not qualify if:

  • weight in the underweight to low normal (BMI \< 22) or morbidly obese (BMI \> 35) ranges
  • current eating disorder or history of eating disorders
  • current major depression or psychotic disorder diagnosis
  • current cardiovascular disease or diabetes diagnosis
  • current participation in a weight loss program
  • current pregnancy
  • previous weight loss surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • Crane MM, Gavin K, Wolfson J, Linde JA. How Accurate are Recalls of Self-Weighing Frequency? Data from a 24-Month Randomized Trial. Obesity (Silver Spring). 2018 Aug;26(8):1296-1302. doi: 10.1002/oby.22239. Epub 2018 Aug 1.

    PMID: 30070045DERIVED

Related Links

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Linde, PhD

    University of Minnesota

    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

July 18, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

US(1)