Self-Weighing Instruction Feasibility Study

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01966926
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Body Weight	Behavioral: weighing frequency instructions and tips	N/A

Detailed Description

This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months. It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions. Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Self-Weighing Instruction Feasibility Study
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daily Weight Tracking weighing frequency instructions and tips	Behavioral: weighing frequency instructions and tips; Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
Experimental: Weekly Weight Tracking weighing frequency instructions and tips	Behavioral: weighing frequency instructions and tips; Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks

Outcome Measures

Primary Outcome Measures

1. Adherence to Weight Tracking Instructions [6 months]

   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).

Secondary Outcome Measures

1. Changes in Depression Ratings [baseline to 6 months]

   Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.

2. Changes in Anxiety [baseline to 6 months]

   Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.

3. Changes in Body Image [baseline to 6 months]

   Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.

4. Changes in Barriers to Weight Tracking [baseline to 6 months]

   Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.

5. Changes in Perceptions of Weight Tracking [three to six months]

   Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Body mass index between 25 and 35 kg/m2

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Jennifer A Linde, Ph.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01966926
• Other Study ID Numbers: 0807S41483
• First Posted: Oct 22, 2013
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by University of Minnesota: self monitoring; self weighing; weight tracking; psychosocial outcomes; feasibility
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

Participant Flow

Recruitment Details	Participants recruited in Sept-Oct 2009 from craigslist.com ads and flyers in a University of Minnesota office building. 58 contacted the study and 28 were excluded [did not complete screening (n=10), not eligible due to weight or health exclusions (n=15), or withdrew before consent (n=3)], resulting in a final sample of 30 participants.

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking	Total
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (9.5)	46.4 (13.8)	45.7 (11.7)
Sex: Female, Male (Count of Participants)
Female	10 66.7%	11 73.3%	21 70%
Male	5 33.3%	4 26.7%	9 30%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.99 (2.97)	31.08 (3.37)	31.04 (3.12)

Outcome Measures

1. Primary Outcome

Title	Adherence to Weight Tracking Instructions
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All participants were included in the analysis.

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Measure Participants	15	15
Number [percentage of postcards returned]	98.3	96.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Weight Tracking, Weekly Weight Tracking
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power not calculated due to small sample size and pilot study intent.
Statistical Test of Hypothesis	p-Value	.15
	Comments	P-value was unadjusted, with an a priori threshold for statistical significance set at p <.05.
	Method	Chi-squared
	Comments	1 degree of freedom
Method of Estimation	Estimation Parameter	chi square
	Estimated Value	2.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Changes in Depression Ratings
Description	Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Measure Participants	15	15
baseline depression	3.6 (3.5)	6.3 (4.4)
3-month depression	3.9 (4.4)	7.1 (4.1)
6-month depression	4.8 (5.6)	6.7 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Weight Tracking, Weekly Weight Tracking
	Comments	Repeated measures analysis from baseline to six months.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power not calculated due to small sample size and pilot study intent.
Statistical Test of Hypothesis	p-Value	0.61
	Comments	P-value not adjusted for multiple comparisons; a priori threshold of <0.05 for statistical significance
	Method	MANOVA
	Comments	Degrees of freedom: 2,27
Method of Estimation	Estimation Parameter	Wilks' Lambda
	Estimated Value	0.96
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Changes in Anxiety
Description	Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Measure Participants	15	15
baseline anxiety	2.3 (2.9)	5.7 (5.0)
3-month anxiety	2.7 (3.5)	5.8 (4.5)
6-month anxiety	3.9 (6.0)	5.3 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Weight Tracking, Weekly Weight Tracking
	Comments	Repeated measures analysis from baseline to six months.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power not calculated due to small sample size and pilot study intent.
Statistical Test of Hypothesis	p-Value	0.50
	Comments	P-value is unadjusted; a priori threshold for statistical significance was <0.05.
	Method	MANOVA
	Comments	Degrees of freedom: 2,27
Method of Estimation	Estimation Parameter	Wilks' Lambda
	Estimated Value	0.95
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Changes in Body Image
Description	Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Measure Participants	15	15
baseline body image	20.1 (7.0)	19.1 (8.0)
3-month body image	22.6 (4.9)	17.9 (8.6)
6-month body image	21.4 (5.9)	18.5 (8.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Weight Tracking, Weekly Weight Tracking
	Comments	Repeated measures analysis from baseline to six months.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power not calculated due to small sample size and pilot study intent.
Statistical Test of Hypothesis	p-Value	0.15
	Comments	P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was <0.05.
	Method	MANOVA
	Comments	Degrees of freedom: 2,27
Method of Estimation	Estimation Parameter	Wilks' Lambda
	Estimated Value	0.87
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Changes in Barriers to Weight Tracking
Description	Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Time Frame	baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Measure Participants	14	15
baseline barriers	39.7 (13.1)	46.7 (14.7)
3-month barriers	27.5 (9.0)	37.3 (9.5)
6-month barriers	30.7 (12.9)	34.3 (12.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Weight Tracking, Weekly Weight Tracking
	Comments	Repeated measures analysis from baseline to six months.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power not calculated due to small sample size and pilot study intent.
Statistical Test of Hypothesis	p-Value	0.30
	Comments	P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was <0.05.
	Method	MANOVA
	Comments	Degrees of freedom: 2,26
Method of Estimation	Estimation Parameter	Wilks' Lambda
	Estimated Value	0.91
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Changes in Perceptions of Weight Tracking
Description	Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Time Frame	three to six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Daily Weight Tracking	Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips	weekly weighing frequency instructions and tips
Measure Participants	15	15
3-month perceptions	47.7 (10.6)	40.4 (10.2)
6-month perceptions	48.2 (10.0)	45.0 (7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Daily Weight Tracking, Weekly Weight Tracking
	Comments	Repeated measures analysis from three to six months.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	Power not calculated due to small sample size and pilot study intent.
Statistical Test of Hypothesis	p-Value	0.17
	Comments	P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was <0.05.
	Method	MANOVA
	Comments	Degrees of freedom: 1,28
Method of Estimation	Estimation Parameter	Wilks' Lambda
	Estimated Value	0.93
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Daily Weight Tracking		Weekly Weight Tracking
Arm/Group Description	daily weighing frequency instructions and tips		weekly weighing frequency instructions and tips
All Cause Mortality
	Daily Weight Tracking		Weekly Weight Tracking
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Daily Weight Tracking		Weekly Weight Tracking
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Daily Weight Tracking		Weekly Weight Tracking
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.