ObesityHEC4LNCT01096719
The Healthy Eating Choices for Life Program
A study testing Standard Behavioral Weight Loss Intervention, Dietary Goal: Reduction in Energy Density of Dietary Intake and Dietary Goal: Reduction of Energy Intake in people with Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Behavioral Weight Loss Intervention, Dietary Goal: Reduction in Energy Density of Dietary Intake and Dietary Goal: Reduction of Energy Intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Aug 2011
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years
- Body mass index (BMI) between 25 and 45 kg/m2
Who cannot join
- Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)
- Report being unable to walk for 2 blocks (1/4 mile) without stopping
- Report major psychiatric diseases/organic brain syndromes via a phone screen
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months
- Intend to move to another city within the time frame of the investigation
- Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation
- Have had gastric surgery for weight loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory
Knoxville, Tennessee, 37996-1920
About this study
Official title: The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.
The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.
Read the detailed description
Given the current prevalence of overweight and obesity among adults in the United States and the projected increase of these conditions in the future, development of effective weight loss and weight loss maintenance strategies is imperative. For weight loss to occur, energy intake needs to be reduced to incur an energy deficit, and for successful weight loss maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels due to an overall reduction in body size which reduces basal metabolic rate. One dietary strategy that may facilitate weight loss maintenance is consuming a diet low in dietary energy density (ED). This pilot study will test the effects of a dietary prescription focused on ED.
All participants in the investigation will receive a standard 12-week behavioral obesity intervention. The intervention will include an activity goal that participants will gradually work to achieve over the course of the 12-week intervention along with standard behavioral weight loss strategies. One condition will receive a dietary prescription for weight loss that focuses solely on lowering the ED of the diet, another condition will receive the traditional dietary prescription used in behavioral weight loss interventions that reduces energy intake, and the third condition will receive both prescriptions. Pre and post intervention measurements will be taken to determine if there are differences between groups.
- Conditions
- Obesity
- Being tested
- Standard Behavioral Weight Loss Intervention, Dietary Goal: Reduction in Energy Density of Dietary Intake, Dietary Goal: Reduction of Energy Intake
- Keywords
- Weight, Dietary intake, Energy Density, Behavioral, Satiety, Deprivation, Hunger, Fruit, Vegetable
- Medical subject headings
- Obesity, Body Weight, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Behavioral Weight Loss InterventionBehavioural
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Dietary Goal: Reduction in Energy Density of Dietary IntakeBehavioural
Consume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day.
Dietary Goal: Reduction of Energy IntakeBehavioural
Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.
| Study group | Role | What they receive |
|---|---|---|
| Energy Density | Experimental | Not described Receives: Behavioral: Standard Behavioral Weight Loss Intervention; Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake |
| Lifestyle Treatment | Active comparator | Not described Receives: Behavioral: Standard Behavioral Weight Loss Intervention; Behavioral: Dietary Goal: Reduction of Energy Intake |
| Energy Density + Lifestyle Treatment | Experimental | Not described Receives: Behavioral: Standard Behavioral Weight Loss Intervention; Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake; Behavioral: Dietary Goal: Reduction of Energy Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy density of the diet
Energy density is defined as the kilocalories per gram of a food. Energy density will be measured by collecting and analyzing 3-day food records using Nutrition Data Systems for Research at baseline (week 0) and post intervention (week 13).
Measured: Weeks 0 and 13
Secondary outcomes (3)
Weight Loss
Measured: Weeks 0 and 13
Feelings of dietary deprivation and satisfaction
Dietary deprivation and satisfaction will be measures using 100mm visual analog scales with the statements "I feel like I ate enough today" and "I feel like I ate what I wanted today". Both scales are anchored with "strongly disagree" on one end and "strongly agree" on the other end. These will be collected for 7 days at baseline (week 0) and post intervention (week 13).
Measured: Weeks 0 and 13
Hunger
Hunger will be measured using a 100mm visual analog scale. The scale asks "How hungry did you feel today?" and is anchored with "not at all hungry" on one end and "extremely hungry" on the other. Hunger scales will be collected for 7 days at baseline (week 0) and post intervention (week 13).
Measured: Weeks 0 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie A Raynor, PhD, RD, LDN, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096719
- Sponsor's protocol ID
- IRB 8107 B
- Acronym
- HEC4L
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2010
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Raynor HA, Steeves EA, Hecht J, Fava JL, Wing RR. Limiting variety in non-nutrient-dense, energy-dense foods during a lifestyle intervention: a randomized controlled trial. Am J Clin Nutr. 2012 Jun;95(6):1305-14. doi: 10.3945/ajcn.111.031153. Epub 2012 May 2.
PubMed 22552025
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.
- ClinicalTrials.gov ID
- NCT01096719
- Acronym / sponsor ID
- HEC4L / IRB 8107 B
- Conditions
- Obesity
- Keywords
- Weight, Dietary intake, Energy Density, Behavioral, Satiety, Deprivation, Hunger, Fruit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 31 Mar 2010 (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 purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.
Detailed description
Given the current prevalence of overweight and obesity among adults in the United States and the projected increase of these conditions in the future, development of effective weight loss and weight loss maintenance strategies is imperative. For weight loss to occur, energy intake needs to be reduced to incur an energy deficit, and for successful weight loss maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels due to an overall reduction in body size which reduces basal metabolic rate. One dietary strategy that may facilitate weight loss maintenance is consuming a diet low in dietary energy density (ED). This pilot study will test the effects of a dietary prescription focused on ED.
All participants in the investigation will receive a standard 12-week behavioral obesity intervention. The intervention will include an activity goal that participants will gradually work to achieve over the course of the 12-week intervention along with standard behavioral weight loss strategies. One condition will receive a dietary prescription for weight loss that focuses solely on lowering the ED of the diet, another condition will receive the traditional dietary prescription used in behavioral weight loss interventions that reduces energy intake, and the third condition will receive both prescriptions. Pre and post intervention measurements will be taken to determine if there are differences between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Energy Density | Experimental | Behavioral: Standard Behavioral Weight Loss Intervention, Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake |
| Lifestyle Treatment | Active comparator | Behavioral: Standard Behavioral Weight Loss Intervention, Behavioral: Dietary Goal: Reduction of Energy Intake |
| Energy Density + Lifestyle Treatment | Experimental | Behavioral: Standard Behavioral Weight Loss Intervention, Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake, Behavioral: Dietary Goal: Reduction of Energy Intake |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 21 and 65 years
- Body mass index (BMI) between 25 and 45 kg/m2
Key exclusion criteria (7 listed)
- Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)
- Report being unable to walk for 2 blocks (1/4 mile) without stopping
- Report major psychiatric diseases/organic brain syndromes via a phone screen
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months
- Intend to move to another city within the time frame of the investigation
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 |
|---|---|---|
| Standard Behavioral Weight Loss Intervention12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies | Behavioural | Energy Density, Energy Density + Lifestyle Treatment, Lifestyle Treatment |
| Dietary Goal: Reduction in Energy Density of Dietary IntakeConsume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day. | Behavioural | Energy Density, Energy Density + Lifestyle Treatment |
| Dietary Goal: Reduction of Energy IntakeLimit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat. | Behavioural | Energy Density + Lifestyle Treatment, Lifestyle Treatment |
Primary outcome
Energy density of the diet
Time frame: Weeks 0 and 13
Energy density is defined as the kilocalories per gram of a food. Energy density will be measured by collecting and analyzing 3-day food records using Nutrition Data Systems for Research at baseline (week 0) and post intervention (week 13).
3 secondary outcomes
Weight Loss
Time frame: Weeks 0 and 13
Feelings of dietary deprivation and satisfaction
Time frame: Weeks 0 and 13
Hunger
Time frame: Weeks 0 and 13
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 5 Apr 2018.
- Derived from this study: PubMed 22552025Raynor HA, Steeves EA, Hecht J, Fava JL, Wing RR. Limiting variety in non-nutrient-dense, energy-dense foods during a lifestyle intervention: a randomized controlled trial. Am J Clin Nutr. 2012 Jun;95(6):1305-14. doi: 10.3945/ajcn.111.031153. Epub 2012 May 2.
- Healthy Eating and Activity Laboratory HomepageLink provided by the sponsor.
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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.
Hollie A Raynor, PhD, RD, LDN principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Behavioral Weight Loss Intervention, Dietary Goal: Reduction in Energy Density of Dietary Intake and Dietary Goal: Reduction of Energy Intake in people with Obesity, run by The University of Tennessee, Knoxville 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 2 inclusion and 7 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 5 Apr 2018. 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?
Energy density of the diet (time frame: Weeks 0 and 13). 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 NCT01096719, which also lists 1 linked publication.
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 5 Apr 2018.