NCT01966926

Brief Summary

Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 7, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 16, 2013

Results QC Date

October 22, 2013

Last Update Submit

October 30, 2019

Conditions

Keywords

self monitoringself weighingweight trackingpsychosocial outcomesfeasibility

Outcome Measures

Primary Outcomes (1)

  • Adherence to Weight Tracking Instructions

    Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).

    6 months

Secondary Outcomes (5)

  • Changes in Depression Ratings

    baseline to 6 months

  • Changes in Anxiety

    baseline to 6 months

  • Changes in Body Image

    baseline to 6 months

  • Changes in Barriers to Weight Tracking

    baseline to 6 months

  • Changes in Perceptions of Weight Tracking

    three to six months

Study Arms (2)

Daily Weight Tracking

EXPERIMENTAL

weighing frequency instructions and tips

Behavioral: weighing frequency instructions and tips

Weekly Weight Tracking

EXPERIMENTAL

weighing frequency instructions and tips

Behavioral: weighing frequency instructions and tips

Interventions

Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks

Daily Weight TrackingWeekly Weight Tracking

Eligibility Criteria

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

You may qualify if:

  • Body mass index between 25 and 35 kg/m2

You may not qualify if:

  • Current weight loss program participation
  • Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
  • Current or past eating disorder
  • Current pregnancy or pregnant in past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Weight LossBody Weight

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical Procedures

Limitations and Caveats

Small sample size; Absence of instructions that would mimic a weight loss program.

Results Point of Contact

Title
Dr. Jennifer Linde
Organization
University of Minnesota

Study Officials

  • Jennifer A Linde, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 22, 2013

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

November 1, 2019

Results First Posted

February 7, 2014

Record last verified: 2019-10

Locations