NCT03273491

Brief Summary

The primary objective of this study is to experimentally test the momentary and more distal psychological effects of daily self weighing as compared to an active control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

September 1, 2017

Last Update Submit

October 3, 2018

Conditions

Daily Self-weighingDaily Temperature-taking

Keywords

self-weighingweight gainEcological Momentary Assessmentmoodemerging adulthoodobesityeating disorders

Outcome Measures

Primary Outcomes (1)

  • psychological response to daily self-weighing

    1. Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking 2. There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day. 3. The daily self-weighing group will report significantly more weight control behaviors at the end of the day as compared to the daily temperature-taking group.

    3 Months

Secondary Outcomes (1)

  • Identify moderators of response to daily self-weighing in a college-aged female population

    3 Months

Study Arms (2)

Daily Self-Weighing Group

EXPERIMENTAL

Participants will be provided with a scale and instructions necessary to engage in daily self-weighing, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.

Behavioral: daily self-weighing

Daily Temperature-Taking Group

ACTIVE COMPARATOR

Participants will be provided with a thermometer and instructions necessary to engage in daily temperature-taking, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT.

Behavioral: daily temperature-taking

Interventions

daily self-weighingBEHAVIORAL

Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.

Daily Self-Weighing Group
daily temperature-takingBEHAVIORAL

Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.

Daily Temperature-Taking Group

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Between the ages of 18 and 26
  • UD student
  • Owns a smart phone
  • If participant does not currently have an eating disorder or has never had one in the past

You may not qualify if:

  • If participant currently has an eating disorder or has had one in the past
  • If participant answers "yes" to 3 or more items in SCOFF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

MeSH Terms

Conditions

Weight GainObesityFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (2C1001)

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 6, 2017

Study Start

June 1, 2017

Primary Completion

December 20, 2017

Study Completion

December 29, 2017

Last Updated

October 4, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)