ObesityNCT01849627
Eat Well for Life: A Weight Loss Maintenance Study
A study testing Low-ED and Energy Balance in people with Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily energy intake at estimated energy needs for maintenance) on weight loss maintenance. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low-ED and Energy Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 31 Dec 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Body mass index (BMI) between 27 and 45 kg/m2
Who cannot join
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate
- Report being unable to walk for 2 blocks (1/4 mile) without stopping
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost > 5% of body weight during the past 6 months
- Have had bariatric surgery for weight loss or are planning to have bariatric surgery in the next 22 months
Show all 10Show fewer
- Intend to move outside of the metropolitan area within the time frame of the investigation
- Are pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation
- Report not being able to consume meal replacements
- To participate in the weight loss maintenance phase, participants will need to lose equal to or greater than 8% of their body weight from the baseline measure at the conclusion of the 4-month weight loss phase.
Trial locations and contacts
1 site in 1 country.
About this study
A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily energy intake at estimated energy needs for maintenance) on weight loss maintenance.
Read the detailed description
Obesity increases the risk of several health conditions. Weight loss of 5-10% of initial weight reduces the risk of several diseases. This degree of weight loss is achievable in behavioral obesity programs. However, about 33% of initial weight loss is regained within one year and very little weight loss is maintained within three to five years. Thus, new strategies improving long-term weight loss maintenance are needed. One dietary strategy that increases self-reported satiation and satiety is consuming a low energy density (ED) diet. A low-ED diet allows a greater weight of food relative to total energy to be consumed, which is the proposed mechanism for the enhanced self-reported satiation and satiety found with low-ED meals. Research has shown that when participants are served low-ED meals, while total weight of food consumed does not change, meal energy intake decreases. Importantly, when low-ED meals are consumed across several days, reduced energy intake continues to occur, showing no degree of energy intake compensation. To address the gaps regarding the relationship between dietary ED and weight loss maintenance, we propose to conduct a randomized controlled trial (RCT) examining the effect of a low-ED prescription and its proposed mechanisms on weight loss maintenance.
The primary hypotheses are:
- Low-ED will have less weight regain than Energy Balance at 22 months.
- Weight regain at 10, 16, and 22 months will be examined to determine if differences occur between conditions.
- Low-ED will consume a lower ED diet, less energy and percent energy from fat, and greater grams from solid food and fiber than Energy Balance at 10, 16, and 22 months. The secondary hypotheses are:
- Identify mechanisms (mediators) by which reducing ED improves long-term lower energy intake, thus:
- Low-ED will self-report lower hunger and greater satiation and satiety during EMA than Energy Balance at 10, 16, and 22 months.
- Conditions
- Obesity
- Being tested
- Low-ED, Energy Balance
- Keywords
- weight loss maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-EDBehavioural
This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day.
Energy BalanceBehavioural
Energy Balance will receive an individualized daily energy goal which will be their measured resting metabolic rate multiplied by a physical activity level (PAL) of 1.12 (men) or 1.14 (women) (low active).
| Study group | Role | What they receive |
|---|---|---|
| Low-ED | Experimental | This condition will focus lowering on the energy density of the diet of the diet. This prescription does not include goals for any other nutrients, thus there are no energy goals. Receives: Behavioral: Low-ED |
| Energy Balance | Experimental | This condition will focus have an energy balance prescription. Participants will be asked to consume a daily energy intake at estimated energy needs for weight loss maintenance. Receives: Behavioral: Energy Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months
Height, weight, and BMI will be assessed.
Measured: 0, 4, 10, 16, and 22 months
Changes in diet from baseline at 4, 10, 16, and 22 months
Three day food records will be used to assess energy, grams, energy density, macronutrients, fiber, and food group servings.
Measured: 0, 4, 10, 16, and 22 months
Secondary outcomes (1)
Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months
Changes in EMA measures on hunger, satiation, and satiety will be assessed.
Measured: 0, 4, 10, 16, and 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)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
- 345 participants (estimated)
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
- NCT01849627
- Sponsor's protocol ID
- 9141B
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2013
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Engelgau MM, Geiss LS, Saaddine JB, Boyle JP, Benjamin SM, Gregg EW, Tierney EF, Rios-Burrows N, Mokdad AH, Ford ES, Imperatore G, Narayan KM. The evolving diabetes burden in the United States. Ann Intern Med. 2004 Jun 1;140(11):945-50. doi: 10.7326/0003-4819-140-11-200406010-00035.
PubMed 15172919Field AE, Coakley EH, Must A, Spadano JL, Laird N, Dietz WH, Rimm E, Colditz GA. Impact of overweight on the risk of developing common chronic diseases during a 10-year period. Arch Intern Med. 2001 Jul 9;161(13):1581-6. doi: 10.1001/archinte.161.13.1581.
PubMed 11434789Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
PubMed 19299006Neter JE, Stam BE, Kok FJ, Grobbee DE, Geleijnse JM. Influence of weight reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertension. 2003 Nov;42(5):878-84. doi: 10.1161/01.HYP.0000094221.86888.AE. Epub 2003 Sep 15.
PubMed 12975389Klein S, Burke LE, Bray GA, Blair S, Allison DB, Pi-Sunyer X, Hong Y, Eckel RH; American Heart Association Council on Nutrition, Physical Activity, and Metabolism. Clinical implications of obesity with specific focus on cardiovascular disease: a statement for professionals from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: endorsed by the American College of Cardiology Foundation. Circulation. 2004 Nov 2;110(18):2952-67. doi: 10.1161/01.CIR.0000145546.97738.1E. Epub 2004 Oct 27.
PubMed 15509809Pi-Sunyer FX. How effective are lifestyle changes in the prevention of type 2 diabetes mellitus? Nutr Rev. 2007 Mar;65(3):101-10. doi: 10.1111/j.1753-4887.2007.tb00287.x.
PubMed 17425061Foster GD, Makris AP, Bailer BA. Behavioral treatment of obesity. Am J Clin Nutr. 2005 Jul;82(1 Suppl):230S-235S. doi: 10.1093/ajcn/82.1.230S.
PubMed 16002827Wadden TA, Crerand CE, Brock J. Behavioral treatment of obesity. Psychiatr Clin North Am. 2005 Mar;28(1):151-70, ix. doi: 10.1016/j.psc.2004.09.008. No abstract available.
PubMed 15733617Jeffery RW, Drewnowski A, Epstein LH, Stunkard AJ, Wilson GT, Wing RR, Hill DR. Long-term maintenance of weight loss: current status. Health Psychol. 2000 Jan;19(1S):5-16. doi: 10.1037/0278-6133.19.suppl1.5.
PubMed 10709944Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
PubMed 22029981Havel PJ. Peripheral signals conveying metabolic information to the brain: short-term and long-term regulation of food intake and energy homeostasis. Exp Biol Med (Maywood). 2001 Dec;226(11):963-77. doi: 10.1177/153537020122601102.
PubMed 11743131Karhunen L, Lyly M, Lapvetelainen A, Kolehmainen M, Laaksonen DE, Lahteenmaki L, Poutanen K. Psychobehavioural factors are more strongly associated with successful weight management than predetermined satiety effect or other characteristics of diet. J Obes. 2012;2012:274068. doi: 10.1155/2012/274068. Epub 2012 Jun 25.
PubMed 22792447Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.
PubMed 22735432Rolls BJ, Drewnowski A, Ledikwe JH. Changing the energy density of the diet as a strategy for weight management. J Am Diet Assoc. 2005 May;105(5 Suppl 1):S98-103. doi: 10.1016/j.jada.2005.02.033.
PubMed 15867904Rolls BJ. The relationship between dietary energy density and energy intake. Physiol Behav. 2009 Jul 14;97(5):609-15. doi: 10.1016/j.physbeh.2009.03.011. Epub 2009 Mar 20.
PubMed 19303887
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat Well for Life: A Weight Loss Maintenance Study
- ClinicalTrials.gov ID
- NCT01849627
- Acronym / sponsor ID
- 9141B
- Conditions
- Obesity
- Keywords
- weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 May 2013 (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.
A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily energy intake at estimated energy needs for maintenance) on weight loss maintenance.
Detailed description
Obesity increases the risk of several health conditions. Weight loss of 5-10% of initial weight reduces the risk of several diseases. This degree of weight loss is achievable in behavioral obesity programs. However, about 33% of initial weight loss is regained within one year and very little weight loss is maintained within three to five years. Thus, new strategies improving long-term weight loss maintenance are needed. One dietary strategy that increases self-reported satiation and satiety is consuming a low energy density (ED) diet. A low-ED diet allows a greater weight of food relative to total energy to be consumed, which is the proposed mechanism for the enhanced self-reported satiation and satiety found with low-ED meals. Research has shown that when participants are served low-ED meals, while total weight of food consumed does not change, meal energy intake decreases. Importantly, when low-ED meals are consumed across several days, reduced energy intake continues to occur, showing no degree of energy intake compensation. To address the gaps regarding the relationship between dietary ED and weight loss maintenance, we propose to conduct a randomized controlled trial (RCT) examining the effect of a low-ED prescription and its proposed mechanisms on weight loss maintenance.
The primary hypotheses are:
- Low-ED will have less weight regain than Energy Balance at 22 months.
- Weight regain at 10, 16, and 22 months will be examined to determine if differences occur between conditions.
- Low-ED will consume a lower ED diet, less energy and percent energy from fat, and greater grams from solid food and fiber than Energy Balance at 10, 16, and 22 months. The secondary hypotheses are:
- Identify mechanisms (mediators) by which reducing ED improves long-term lower energy intake, thus:
- Low-ED will self-report lower hunger and greater satiation and satiety during EMA than Energy Balance at 10, 16, and 22 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-ED | Experimental | Behavioral: Low-EDThis condition will focus lowering on the energy density of the diet of the diet. This prescription does not include goals for any other nutrients, thus there are no energy goals. |
| Energy Balance | Experimental | Behavioral: Energy BalanceThis condition will focus have an energy balance prescription. Participants will be asked to consume a daily energy intake at estimated energy needs for weight loss maintenance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 70 years
- Body mass index (BMI) between 27 and 45 kg/m2
Key exclusion criteria (10 listed)
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate
- Report being unable to walk for 2 blocks (1/4 mile) without stopping
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost > 5% of body weight during the past 6 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 |
|---|---|---|
| Low-EDThis condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day. | Behavioural | Low-ED |
| Energy BalanceEnergy Balance will receive an individualized daily energy goal which will be their measured resting metabolic rate multiplied by a physical activity level (PAL) of 1.12 (men) or 1.14 (women) (low active). | Behavioural | Energy Balance |
Primary outcome
Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months
Time frame: 0, 4, 10, 16, and 22 months
Height, weight, and BMI will be assessed.
Changes in diet from baseline at 4, 10, 16, and 22 months
Time frame: 0, 4, 10, 16, and 22 months
Three day food records will be used to assess energy, grams, energy density, macronutrients, fiber, and food group servings.
1 secondary outcome
Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months
Time frame: 0, 4, 10, 16, and 22 months
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 9 Jun 2026.
- Background: PubMed 15172919Engelgau MM, Geiss LS, Saaddine JB, Boyle JP, Benjamin SM, Gregg EW, Tierney EF, Rios-Burrows N, Mokdad AH, Ford ES, Imperatore G, Narayan KM. The evolving diabetes burden in the United States. Ann Intern Med. 2004 Jun 1;140(11):945-50. doi: 10.7326/0003-4819-140-11-200406010-00035.
- Background: PubMed 11434789Field AE, Coakley EH, Must A, Spadano JL, Laird N, Dietz WH, Rimm E, Colditz GA. Impact of overweight on the risk of developing common chronic diseases during a 10-year period. Arch Intern Med. 2001 Jul 9;161(13):1581-6. doi: 10.1001/archinte.161.13.1581.
- Background: PubMed 19299006Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
- Background: PubMed 12975389Neter JE, Stam BE, Kok FJ, Grobbee DE, Geleijnse JM. Influence of weight reduction on blood pressure: a meta-analysis of randomized controlled trials. Hypertension. 2003 Nov;42(5):878-84. doi: 10.1161/01.HYP.0000094221.86888.AE. Epub 2003 Sep 15.
- Background: PubMed 15509809Klein S, Burke LE, Bray GA, Blair S, Allison DB, Pi-Sunyer X, Hong Y, Eckel RH; American Heart Association Council on Nutrition, Physical Activity, and Metabolism. Clinical implications of obesity with specific focus on cardiovascular disease: a statement for professionals from the American Heart Association Council on Nutrition, Physical Activity, and Metabolism: endorsed by the American College of Cardiology Foundation. Circulation. 2004 Nov 2;110(18):2952-67. doi: 10.1161/01.CIR.0000145546.97738.1E. Epub 2004 Oct 27.
- Background: PubMed 17425061Pi-Sunyer FX. How effective are lifestyle changes in the prevention of type 2 diabetes mellitus? Nutr Rev. 2007 Mar;65(3):101-10. doi: 10.1111/j.1753-4887.2007.tb00287.x.
- Background: PubMed 16002827Foster GD, Makris AP, Bailer BA. Behavioral treatment of obesity. Am J Clin Nutr. 2005 Jul;82(1 Suppl):230S-235S. doi: 10.1093/ajcn/82.1.230S.
- Background: PubMed 15733617Wadden TA, Crerand CE, Brock J. Behavioral treatment of obesity. Psychiatr Clin North Am. 2005 Mar;28(1):151-70, ix. doi: 10.1016/j.psc.2004.09.008. No abstract available.
- Background: PubMed 10709944Jeffery RW, Drewnowski A, Epstein LH, Stunkard AJ, Wilson GT, Wing RR, Hill DR. Long-term maintenance of weight loss: current status. Health Psychol. 2000 Jan;19(1S):5-16. doi: 10.1037/0278-6133.19.suppl1.5.
- Background: PubMed 22029981Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
- Background: PubMed 11743131Havel PJ. Peripheral signals conveying metabolic information to the brain: short-term and long-term regulation of food intake and energy homeostasis. Exp Biol Med (Maywood). 2001 Dec;226(11):963-77. doi: 10.1177/153537020122601102.
- Background: PubMed 22792447Karhunen L, Lyly M, Lapvetelainen A, Kolehmainen M, Laaksonen DE, Lahteenmaki L, Poutanen K. Psychobehavioural factors are more strongly associated with successful weight management than predetermined satiety effect or other characteristics of diet. J Obes. 2012;2012:274068. doi: 10.1155/2012/274068. Epub 2012 Jun 25.
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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 Low-ED and Energy Balance 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 10 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 9 Jun 2026. 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 Anthropometrics from Baseline at 4, 10, 16, and 22 months (time frame: 0, 4, 10, 16, and 22 months). The study lists 2 primary outcomes in all. 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 NCT01849627, which also lists 53 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 9 Jun 2026.