ObesityNCT01474759
Portion Size Strategies for Management of Body Weight
A study testing Advice on diet, physical activity, and behavior change, Instruction in food portion size and Provision of pre-portioned foods in people with Obesity, run by Penn State University at 1 site in United States.
Trial summary
The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Advice on diet, physical activity, and behavior change, Instruction in food portion size and Provision of pre-portioned foods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index of 28 to 45 kg/m squared
- Able to safely engage in physical activity (walking)
- Able to attend regular instructional sessions at University Park, Pennsylvania
Who cannot join
- have a medical condition diagnosed by a physician that precludes participation
- report symptoms indicative of depression or disordered eating
- report serious food allergies or intolerance
- current or planned participation in a weight-loss program
- pregnant or lactating or planning to become pregnant in the next 18 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University Laboratory for the Study of Human Ingestive Behavior
University Park, Pennsylvania, 16803
About this study
The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. A third group will receive a basic nutritional program to promote weight loss.
The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.
- Conditions
- Obesity
- Being tested
- Advice on diet, physical activity, and behavior change, Instruction in food portion size, Provision of pre-portioned foods, Advice on healthy eating for weight loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advice on diet, physical activity, and behavior changeBehavioural
Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
Instruction in food portion sizeBehavioural
Individuals assigned to this program will participate in individual instructional sessions with specialized materials and tools that address food selection and choosing appropriate portion sizes of various foods.
Provision of pre-portioned foodsOther
Individuals assigned to this program will be provided with commercially available pre-portioned foods and will be taught effective ways to incorporate them into their daily diet.
Advice on healthy eating for weight lossBehavioural
Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.
| Study group | Role | What they receive |
|---|---|---|
| Portion size instruction | Experimental | Advice on diet, physical activity, and behavior change. Instruction in food portion size. Receives: Behavioral: Advice on diet, physical activity, and behavior change; Behavioral: Instruction in food portion size |
| Pre-portioned foods | Experimental | Advice on diet, physical activity, and behavior change. Provision of pre-portioned foods. Receives: Behavioral: Advice on diet, physical activity, and behavior change; Other: Provision of pre-portioned foods |
| Comparison | Active comparator | Advice on diet, physical activity, and behavior change. Advice on healthy eating for weight loss. Receives: Behavioral: Advice on diet, physical activity, and behavior change; Behavioral: Advice on healthy eating for weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight will be measured at multiple time points during the 12-month trial; the main outcome will be the weight trajectory across this time
Measured: Months 0 to 12
Secondary outcomes (10)
Change in portion size selection, perception, and knowledge
Computerized assessment of various foods (for self-selected portion sizes, estimation of calorie content, and satiety value) and general knowledge about portion size
Measured: Months 0, 3, 6, & 12
Change in portion size consumption
Portion sizes consumed in various food categories as assessed by diet recalls and diet records
Measured: Months 0, 3, 6, & 12
Change in blood biomarkers
Fasting lipids, glucose, insulin, and calculated insulin resistance
Measured: Months 0, 3, 6, & 12
Change in waist circumference
Measured: Months 0, 3, 6, & 12
Change in blood pressure
Measured: Months 0, 3, 6, & 12
Change in dietary intakes
Energy intake, nutrient intakes, dietary energy density, food group intakes, and diet quality from three days of 24-hour diet recalls
Measured: Months 0, 3, 6, 9, & 12
Change in step counts
Daily step counts from pedometers
Measured: Months 0, 3, 6, 9, & 12
Change in attitudes and behaviors related to food and eating
Self-reported eating attitudes and behaviors on multiple questionnaires
Measured: Months 0, 1, 3, 6, & 12
Change in psychosocial characteristics
Questionnaires measuring psychosocial characteristics including impulsivity, variety-seeking, and self-efficacy
Measured: Months 0, 3, 6, & 12
Intervention adherence
Number of sessions attended, number of diet and activity records completed, and frequency of using intervention strategies during the entire trial
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara J. Rolls, Penn State University
- Investigators
- Barbara J. Rolls, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474759
- Sponsor's protocol ID
- PortionSize101
- Other IDs
- R01DK059853
- Status last verified
- May 2015
- First submitted
- 15 Nov 2011
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roe LS, Rolls BJ. Which strategies to manage problem foods were related to weight loss in a randomized clinical trial? Appetite. 2020 Aug 1;151:104687. doi: 10.1016/j.appet.2020.104687. Epub 2020 Mar 29.
PubMed 32234531James BL, Loken E, Roe LS, Rolls BJ. The Weight-Related Eating Questionnaire offers a concise alternative to the Three-Factor Eating Questionnaire for measuring eating behaviors related to weight loss. Appetite. 2017 Sep 1;116:108-114. doi: 10.1016/j.appet.2017.04.023. Epub 2017 Apr 22.
PubMed 28442337
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portion Size Strategies for Management of Body Weight
- ClinicalTrials.gov ID
- NCT01474759
- Acronym / sponsor ID
- PortionSize101
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. A third group will receive a basic nutritional program to promote weight loss.
The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Portion size instruction | Experimental | Behavioral: Advice on diet, physical activity, and behavior change, Behavioral: Instruction in food portion sizeAdvice on diet, physical activity, and behavior change. Instruction in food portion size. |
| Pre-portioned foods | Experimental | Behavioral: Advice on diet, physical activity, and behavior change, Other: Provision of pre-portioned foodsAdvice on diet, physical activity, and behavior change. Provision of pre-portioned foods. |
| Comparison | Active comparator | Behavioral: Advice on diet, physical activity, and behavior change, Behavioral: Advice on healthy eating for weight lossAdvice on diet, physical activity, and behavior change. Advice on healthy eating for weight loss. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index of 28 to 45 kg/m squared
- Able to safely engage in physical activity (walking)
- Able to attend regular instructional sessions at University Park, Pennsylvania
Key exclusion criteria (5 listed)
- have a medical condition diagnosed by a physician that precludes participation
- report symptoms indicative of depression or disordered eating
- report serious food allergies or intolerance
- current or planned participation in a weight-loss program
- pregnant or lactating or planning to become pregnant in the next 18 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advice on diet, physical activity, and behavior changeIndividuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss. | Behavioural | Comparison, Portion size instruction, Pre-portioned foods |
| Instruction in food portion sizeIndividuals assigned to this program will participate in individual instructional sessions with specialized materials and tools that address food selection and choosing appropriate portion sizes of various foods. | Behavioural | Portion size instruction |
| Provision of pre-portioned foodsIndividuals assigned to this program will be provided with commercially available pre-portioned foods and will be taught effective ways to incorporate them into their daily diet. | Other | Pre-portioned foods |
| Advice on healthy eating for weight lossIndividuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet. | Behavioural | Comparison |
Primary outcome
Change in body weight
Time frame: Months 0 to 12
Body weight will be measured at multiple time points during the 12-month trial; the main outcome will be the weight trajectory across this time
10 secondary outcomes
Change in portion size selection, perception, and knowledge
Time frame: Months 0, 3, 6, & 12
Change in portion size consumption
Time frame: Months 0, 3, 6, & 12
Change in blood biomarkers
Time frame: Months 0, 3, 6, & 12
Change in waist circumference
Time frame: Months 0, 3, 6, & 12
Change in blood pressure
Time frame: Months 0, 3, 6, & 12
Change in dietary intakes
Time frame: Months 0, 3, 6, 9, & 12
Change in step counts
Time frame: Months 0, 3, 6, 9, & 12
Change in attitudes and behaviors related to food and eating
Time frame: Months 0, 1, 3, 6, & 12
Change in psychosocial characteristics
Time frame: Months 0, 3, 6, & 12
Intervention adherence
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Derived from this study: PubMed 32234531Roe LS, Rolls BJ. Which strategies to manage problem foods were related to weight loss in a randomized clinical trial? Appetite. 2020 Aug 1;151:104687. doi: 10.1016/j.appet.2020.104687. Epub 2020 Mar 29.
- Derived from this study: PubMed 28442337James BL, Loken E, Roe LS, Rolls BJ. The Weight-Related Eating Questionnaire offers a concise alternative to the Three-Factor Eating Questionnaire for measuring eating behaviors related to weight loss. Appetite. 2017 Sep 1;116:108-114. doi: 10.1016/j.appet.2017.04.023. Epub 2017 Apr 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J. Rolls, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice on diet, physical activity, and behavior change, Instruction in food portion size and Provision of pre-portioned foods in people with Obesity, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Months 0 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474759, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.